Explore the complete list of our presses below (Page 25 of 27):
AB Science's US patent for masitinib in biomarker-defined mCRPC extends to May 2042. Key implications for generic manufacturers and oncology IP strategy.
FDA clears Novartis ITVISMA for SMA in patients aged 2 and older. Key GMP, 21 CFR Part 211, and ATMP compliance implications for biologics manufacturers.
FDA's June 2026 TECARTUS label update and 2025 REMS elimination carry direct implications for CAR-T manufacturing controls and post-market regulatory strategy.
FDA clears Norwich Pharmaceuticals' generic baloxavir marboxil tablets ahead of the 2026–2027 flu season, opening competition with Genentech's Xofluza.
Siegfried's new German API facility adds 100 m³ reactor capacity for small-molecule CDMOs. Key implications for DMF holders, QA directors, and procurement leads.
Suven reports positive Phase 2b data for ropanicant in major depressive disorder. Global Phase 3 planning underway, raising CMC and regulatory readiness questions.
Lupin secures 180-day U.S. exclusivity for generic Azilsartan Medoxomil after FDA ANDA approval. Reference drug Edarbi posted USD 53.5M in annual U.S. sales.
Axcelead DDP becomes the first CRO on Lilly TuneLab, accessing AI models for ADME and safety prediction to improve early-stage drug candidate quality.
Allergan's SKINVIVE by JUVÉDERM gains FDA clearance as the first HA injectable for neck lines. Key GMP and combination-product regulatory implications for manufacturers.
Nicox's China licensee Ocumension receives positive CDE pre-submission feedback for NCX 470 glaucoma eye drop, clearing the path for a China NDA after the U.S. filing in summer 2026.
FDA accepts Roche's sBLA for subcutaneous Lunsumio VELO plus Polivy in relapsed/refractory LBCL. Decision expected February 2027. Key regulatory and QA implications.
FIBRONEER™ Phase III modeling predicts nerandomilast extends IPF median survival to 9.1 years. Key regulatory and manufacturing implications for NDA/MAA teams.
Kiora Pharmaceuticals reports KIO-300 significantly reduced epileptiform activity in a preclinical TLE model, raising CNS formulation and regulatory strategy questions.
Brinton Pharma names Sathya Narayanan CEO for India and JPAC as mid-tier manufacturers navigate tightening GMP standards across Southeast Asian markets.
FDA's CRL for Grace Therapeutics' GTx-104 NDA cites CMC leachables gaps and CMO cGMP deficiencies. Key lessons for QA and regulatory teams on NDA submissions.
Delaware court invalidates all Novartis AAA patent claims against Curium, clearing U.S. market entry for a second Lu-177 dotatate supplier for GEP-NET therapy.
FDA grants GRI Bio Orphan Drug Designation for GRI-0621 in idiopathic pulmonary fibrosis, unlocking 7-year exclusivity and enhanced regulatory engagement.
Becki Morison joins Essential Pharma as CEO on 1 July 2026, bringing rare disease and specialty pharma leadership from LEO Pharma and Eli Lilly.
FDA issues a ninth approval letter for Novartis Gene Therapies' Zolgensma under BLA 125694 in June 2026, with implications for GMP compliance and post-market obligations.
Teva submits NDA for ecopipam, a first-in-class D1 receptor antagonist with FDA Fast Track and Orphan Drug status, targeting pediatric Tourette syndrome.
Axcelead presents a multi-cell-line global proteomics platform for TPD off-target safety assessment at JSOT 2026, detecting ~10,000 proteins to support IND submissions.
3PBIOVIAN outlines the top GMP pitfalls in recombinant protein manufacturing, from CQA validation to CMC documentation gaps ahead of IND and IMPD filing.
3PBIOVIAN's AAVion platform addresses CMC scrutiny and commercial sustainability in AAV gene therapy manufacturing using DoE, in-house plasmids, and royalty-free backbones.
Japan's MHLW approves Sanofi's subcutaneous Sarclisa (isatuximab) for multiple myeloma. Phase 3 IRAKLIA confirms non-inferiority. CirCLIQ OBI review ongoing.
Zydus Lifesciences acquires Assertio, creating a wholly owned US specialty pharma subsidiary. Key implications for QA, regulatory alignment, and FDA compliance.
Alembic Pharmaceuticals secures USFDA tentative approval for Binimetinib 45 mg tablets as sole first applicant, positioning for 180-day generic exclusivity under Hatch-Waxman.
Cellares and Ori Biotech lead $1.1B in automated cell therapy manufacturing funding. What it means for GMP production models and CDMO strategy in advanced therapies.
Hetero promotes Sameer Garaye to Vice President of pharmaceutical R&D, with a focus on advanced formulation development and innovation at the generics manufacturer.
FDA expands Merck's CAPVAXIVE approval to high-risk children and teens. Key implications for vaccine manufacturing scale-up, process validation, and GMP compliance.
Boehringer Ingelheim initiates Phase III trials for obrixtamig in SCLC and epNEC and zongertinib in HER2-mutant NSCLC, with manufacturing and CDx implications.
Sanofi names Paulo Fontoura EVP, Global Head of R&D Pharma from September 2026, with oversight of regulatory affairs and clinical development across its pipeline.
Cipla elevates Saurabh Gambhir to Chief Strategy Officer (Global). What the appointment signals for international manufacturing, regulatory expansion, and GMP compliance strategy.
AbbVie's $10.9B acquisition of Apogee Therapeutics adds half-life extended mAbs targeting IL-13 and TSLP, with major CMC and biologics manufacturing implications.
Regeneron secures FDA Priority Review and EMA acceptance for cemdisiran in generalized myasthenia gravis. PDUFA date set for November 2026. Key read for regulatory and manufacturing teams.
Nuvectis Pharma licenses NXP100 and NXP200 from Haisco for ex-China rights, triggering FDA/EMA bridging studies and GMP alignment for Western clinical development.
Eledon's tegoprubart shows sustained 12 mL/min/1.73 m² eGFR advantage over tacrolimus at 18 months with zero BPAR events after month six in Phase 2 BESTOW extension.
Aurobindo Pharma USA clears FTC review on its $250M Lannett acquisition, adding U.S. manufacturing capacity and triggering GMP integration obligations.
Zotefoams admits AMCON to its Global Approved Partner Program, giving U.S. buyers regional stockholding, conversion capability, and local technical support for high-performance foam.
Sun Pharma's Rs. 271.2 crore acquisition of Innovcare Lifesciences expands its GMP footprint into nutraceutical and cosmeceutical manufacturing. Deal closes July 2026.
Achieve Life Sciences receives FDA CRL for cytisinicline NDA due to third-party CMO OAI classification. Resubmission planned Q4 2026 with Adare Pharma Solutions.
FibroBiologics secures 19 USPTO-allowed claims covering 3D spheroid fibroblast wound therapy, directly aligned with CYWC628 Phase 1/2 trial in diabetic foot ulcers.
Verrica Pharmaceuticals doses first U.S. patient in COVE-3 Phase 3 trial for YCANTH in common warts, with parallel Japanese enrollment under Torii Pharmaceutical.
Lilly's $7.8B Centessa acquisition closes June 24 after High Court approval. What the OX2R tech transfer means for Lilly's GMP network and CMO strategy.
Elevar Therapeutics initiates ReFocus202 Phase 2 dosing for lirafugratinib in non-CCA solid tumors. FDA PDUFA date set for September 27, 2026 for CCA NDA.
CBER's post-market vaccine surveillance now spans 25+ protocols across COVID-19, RSV, and influenza. What it means for pharmacovigilance and BLA obligations.
CBER regulates HCT/Ps and cell/gene therapy under 21 CFR Parts 1270 and 1271. QA directors entering ATMP manufacturing face distinct cGTP and GMP compliance obligations.
FDA CBER's centralized archive of biologics safety and availability communications spans 2017–2026. A key compliance reference for QA directors and regulatory affairs leads.
Orion Pharma's ODM-212 receives European Commission Orphan Designation for malignant mesothelioma, adding EU incentives to existing FDA orphan status. Phase 2 TEADES trial ongoing.
EC approves AbbVie's risankizumab for pediatric plaque psoriasis with a new 55 mg pre-filled syringe. Key fill-finish and process validation implications for EU manufacturers.
Sanofi's Cenrifki gains EC approval for non-relapsing SPMS with mandatory RMP and liver monitoring. QA and regulatory implications for EU CNS launches.
Japan's MHLW grants Sanofi dual marketing and manufacturing authorization for Wayrilz in ITP. Key CMC and regulatory pathway implications for rare disease sponsors.
FDA's 131 drug approvals in 2025 exceed the 10-year average, driving CMO capacity pressure, process validation demands, and tighter PAI timelines into 2026.
Insmed names Samuele Butera SVP, General Manager, Global Respiratory to lead BRINSUPRI launch, ARIKAYCE label expansion, and TPIP program from June 2026.
European Commission approves AbbVie's MAVIRET for acute HCV in adults and children aged 3+, the only EU-authorized therapy for both acute and chronic infection.
Phathom Pharmaceuticals completes enrollment in Phase 2 pHalcon-EoE-201 vonoprazan EoE trial. Topline data expected Q4 2026 with potential FDA pathway implications.
FDA's CDER issued a warning letter to Novo Nordisk over a misleading DTC video covering Wegovy, Ozempic, and Victoza. Key compliance implications for regulatory teams.
Health Canada approves Boey® (trenibotulinumtoxinE), the world's first botulinum serotype E neurotoxin for aesthetics. Key regulatory and manufacturing implications for biologics teams.
Wesley Pharmaceuticals launches Methylcobalamin, Glutathione, and Magnesium Chloride as 503(b)-compliant multi-dose injectables, expanding outsourcing supply options.
AbbVie's $10.9B acquisition of Apogee Biosciences raises GMP tech transfer, CDMO continuity, and regulatory filing questions for biologics manufacturing teams.
FDA grants Roche Priority Review with a 9 October 2026 decision date for a colon cancer drug. Key manufacturing and pre-approval inspection implications for QA teams.
FDA's Guidance Snapshot Pilot launches with Master Protocols and Bayesian Methodology drafts open for comment. Key read for regulatory affairs and clinical development teams.
FDA updates IND safety reporting guidance under 21 CFR 312.32, covering qualifying event categories, causal relationship standards, and electronic submission rules for IND sponsors.
FDA's final digital health technology guidance sets expectations for remote data acquisition in clinical trials. Key implications for QA, regulatory, and clinical ops teams.
Sun Pharma joins the 2026 S&P Dow Jones Best-in-Class World Index among 317 global companies for sustainability leadership
Biocon secures Malaysia Ministry of Health insulin supply contracts worth over Rs. 515 crore with Duopharma Biotech, covering human insulin, glargine, and aspart.
Cognition Therapeutics secures FDA agreement on zervimesine Phase 3 design for DLB psychosis, including NPI as a novel primary endpoint. Program starts mid-2027.
FDA grants dual first-line TNBC approval for sacituzumab govitecan-hziy as monotherapy and with pembrolizumab. Key implications for ADC manufacturers and QA teams.
Cadrenal Therapeutics presents CAD-1005 Phase 2 data at ISTH 2026, first randomized HIT trial, Phase 3-ready 12-LOX inhibitor with no approved comparator.
Shilpa Biologicals commissions a rare integrated ADC drug substance facility in India, expanding high-potency biologics CDMO capacity for global sponsors.
FDA's Drug Trials Snapshots adds eight 2025 NME and biologic approvals. QA and regulatory teams should note growing expectations on clinical trial demographic diversity.
FDA's PDAC reviews Otsuka's brexpiprazole sNDA for PTSD in combination with sertraline on July 18, 2025. Key implications for sNDA strategy and AdCom preparation.
FDA approves Ionis Pharmaceuticals' olezarsen (Tryngolza) for severe hypertriglyceridemia. First therapy to reduce acute pancreatitis risk raises GMP and ASO manufacturing considerations.
FDA approves Pfizer's Ibrance for HER2-positive metastatic breast cancer maintenance. QA and regulatory teams face updated labeling and post-marketing obligations.
FDA approved BioMarin's ROCTAVIAN for severe hemophilia A with a mandatory companion diagnostic. Key regulatory and QA implications for AAV gene therapy manufacturers.
FDA's February 2026 approval letter for GSK's SHINGRIX marks the ninth BLA action since 2017. Key compliance and labeling implications for QA and regulatory affairs teams.
FDA granted Novartis accelerated approval for Kymriah in relapsed/refractory follicular lymphoma. Confirmatory trial obligations and REMS requirements affect cell therapy manufacturers.
Bavarian Nordic's JYNNEOS has received six FDA approval letters since 2022. QA directors should audit lot expiry records against the latest approved dating under Section 564A and BLA frameworks.
Merck's VARIVAX has logged six-plus FDA approval letters since 2017. A post-approval lifecycle case study for QA directors managing dual-formulation biologics.
Spark Therapeutics' LUXTURNA dual approval record offers QA directors and regulatory leads a CMC benchmark for AAV gene therapy BLA submissions under 21 CFR Part 601.
Octapharma's WILATE has received five FDA approval actions since 2019 across VWD and hemophilia A indications. A key reference for plasma-derived biologics sBLA strategy.
Shilpa Biologicals commissions a rare integrated ADC Drug Substance facility in India, offering end-to-end CDMO capability for complex biologics under GMP.
Atea Pharmaceuticals closes enrollment in Phase 3 C-FORWARD HCV trial with 880+ patients across 17 countries. BEM/RZR topline data expected year-end 2026.
Sandoz India names Vishal Rathi Group Head, Product Development, consolidating generics and biosimilar pipeline leadership amid active USFDA inspection oversight.
Intas Pharmaceuticals names Girish Bhunje SVP – API Operations, reinforcing GMP leadership and supply chain resilience across its API manufacturing network.
ProQR's AX-0810 Phase 1 data confirm first clinical validation of the Axiomer RNA editing platform. Key implications for CDMOs and QA teams on GMP readiness.
ImmuPharma selects Bachem AG as API manufacturing partner for Kapiglucagon glucagon prodrug, advancing CMC development under a planned 505(b)(2) pathway.
Medera's independent DMC recommends MUSIC-HFpEF trial continue without protocol changes. No SAEs reported across 10 patients. FDA discussions on randomized stage ahead.
Merck KGaA's $11.3B acquisition of Bio-Techne reshapes the bioprocessing tools supply chain. Key implications for CMOs, QA directors, and regulatory leads.
AbbVie gains FDA approval for SKYRIZI in pediatric psoriatic disease with a new 55 mg PFS. Key implications for fill-finish validation, device qualification, and supply chain teams.
Total Nutrition Inc. recalls TNVitamins Moringa Capsules and Powder after a supplier flags Salmonella risk. Key read for QA directors on 21 CFR Part 111 supplier controls.
AbbVie's upadacitinib receives positive CHMP opinion for non-segmental vitiligo, potentially the first systemic EU therapy. EC decision expected within months.
AB Science reports 67% ORR and 100% DCR in Phase 1 Step 3 of AB8939 plus venetoclax for relapsed/refractory AML, with no dose-limiting toxicities observed.
Roche's AXELIOS 1 sequencing platform uses SBX technology for same-day whole-genome results. Key implications for pharma genomic QC and biologics characterization.
Strides Pharma sells majority stake in Pivot Path for Rs. 100 crore, reflecting Indian generics consolidation toward GMP-compliant regulated-market manufacturing.
Ipsen acquires Kartos Therapeutics, adding Phase III MDM2 inhibitor navtemadlin for myelofibrosis. CMC and regulatory implications for a potential 2028 approval.
Tonix Pharmaceuticals begins HORIZON Phase 2 study of TNX-102 SL for MDD. Key CMC and GMP implications for QA and regulatory teams managing sublingual tablet supply.
George Medicines names Brendan Walsh SVP of Supply Chain to manage GMRx2's multi-CMO network across eight licensed territories. Details on CMO governance and tech transfer.
FDA approved Orca Bio's Tregzi on June 30, 2026, for matched donor HSCT in hematologic malignancies. Three-component sequential dosing sets a new BLA precedent.
FDA's Q1 2026 AEMS report flags 20-plus serious-risk signals across injectables, oncology, and CNS products. QA and regulatory teams should act now.
Ipsen acquires Memo Therapeutics AG for potravitug, a first-in-class BKPyV monoclonal antibody with FDA fast-track and EU orphan designation. Pivotal trial planned for 2026.
Kowa submits NCX 470 NDA to FDA for open-angle glaucoma, triggering a €3M milestone to Nicox. Mid-2027 approval targeted under standard 12-month review.
Idorsia names Roland Wandeler CEO effective October 2026. The Grifols biopharma president brings 25+ years of global pharma leadership to drive QUVIVIQ and pipeline commercialisation.
Evommune's EVO756 missed its UAS7 primary endpoint at all doses in Phase 2b for chronic spontaneous urticaria, prompting manufacturing scale-down and GMP compliance actions.
Akums secures DCGI approval for a triple-action fixed-dose combination for diabetic peripheral neuropathic pain. Key read for regulatory affairs and QA leads tracking India FDC pathways.
Harrow commercially launches BYOOVIZ (ranibizumab-nuna), the first FDA-designated interchangeable ophthalmology biosimilar, under an exclusive deal with Samsung Bioepis.
Intensity Therapeutics resumes INVINCIBLE-4 enrollment in Q3 2026 and restarts INVINCIBLE-3 at U.S. sites, while seeking pharma partners for INT230-6 intratumoral platform.
Artelo Biosciences reports positive preclinical data for ART26.12 in spinal cord injury neuropathic pain, expanding the FABP5 inhibitor's profile ahead of Phase 1.
60 Degrees Pharmaceuticals' DSMB recommends continuation of B-FREE Phase 2 tafenoquine study in chronic babesiosis, an indication with no FDA-approved treatment.
Telix Pharmaceuticals secures FDA Type B meeting alignment on ProstACT Global Phase 3 statistical framework and safety monitoring plan for TLX591-Tx in mCRPC.
Mankind Pharma partners with Denovo Sciences on AI-powered drug discovery to shorten timelines and improve lead candidate quality. CMC implications examined.
Morepen Laboratories activates commercial supply under an Rs. 825 crore CDMO contract. Key implications for QA directors, plant heads, and supply chain leads.
European Commission approves Novartis Itvisma for SMA patients aged 2 and older. Key GMP, cold-chain, and regulatory implications for pharma ops and QA teams.
Roche's divarasib outperforms sotorasib and adagrasib on PFS and OS in phase III Krascendo 1. FDA and EMA submissions imminent. CMC and regulatory implications inside.
Anaveon promotes Laetitia Pouzol to Chief Scientific Officer to lead IND-enabling studies for ANV200, a PD-1 depleting antibody in autoimmune disease.
Corline Biomedical's 5-year STARS-nob follow-up confirms Renaparin® safety in kidney transplantation and supports the 80-patient RENAPAIR 02 Phase 2 trial.
EMA launches a four-workstream women's health initiative covering CTIS trial data, labelling updates, ICH E21, and DARWIN EU real-world evidence. September workshop shapes next steps.
FDA CBER approved GlaxoSmithKline's Fluarix seasonal strain update in March 2026 under STN BL 125127, shifting the annual approval cycle earlier than prior years.
Syngene names Siddharth Mittal MD and CEO. His 13-year CFO role at Biocon shapes expectations for CDMO expansion, capacity investment, and biopharma partnerships.
Glenmark advances a HER2-targeted ADC into Phase 3 for platinum-resistant ovarian cancer, with GMP and process validation implications for ADC manufacturing teams.
FDA approves Seqirus Flucelvax for 2026–2027 influenza season. Explore GMP and regulatory implications of the MDCK cell-based manufacturing platform.
FDA approves ID Biomedical's FluLaval Quadrivalent for 2026–2027. QA and regulatory teams must act on lot release, labeling updates, and GMP compliance now.
FDA approves Sanofi's Fluzone and Fluzone High-Dose for 2026–27 under STN BL 103914. Key implications for multi-product biologics manufacturing and QA compliance.
Roche's second India digital hub in Hyderabad targets Q1 2027 operations, expanding AI and digital manufacturing capabilities across its global network.
Rockwell Automation and Cisco's new India partnership introduces a software-defined manufacturing framework with key implications for GMP-aligned IT/OT convergence in pharma plants.
WHO's PARTNERS adaptive platform trial opens Bundibugyo virus disease enrolment in DRC, evaluating MBP134 and remdesivir with implications for CDMO surge readiness and emergency regulatory pathways.
WHO added the first BDBV molecular diagnostic to its Emergency Use Listing in under seven weeks post-PHEIC. Key read for IVD manufacturers and regulatory affairs leads.
Avantor named exclusive India distributor for Sartorius filter papers. QA and procurement teams at Indian pharma sites must review approved supplier lists and vendor qualification records.
ReproNovo doses first participant in NORDIC, its EU Phase 2 trial of oral oxytocin receptor antagonist RPN-002 for embryo implantation in IVF and ICSI programs.
Novartis acquires Myricx Bio for up to $1.5bn, adding an NMTi ADC payload platform designed to overcome TOPO-1 resistance in solid tumor settings.
Glenmark launches FDA-approved generic Olanzapine for Injection in the US, targeting a $25.4M market as a therapeutic equivalent to Zyprexa IM.
Cipla names Sushrut Kulkarni Global Chief of Integrated Product Development, consolidating R&D and manufacturing pipeline leadership to sharpen generics competitiveness.
Moleculin Biotech releases preliminary Phase 2/3 MIRACLE trial data for Annamycin in R/R AML. Early efficacy signals from 45 patients; statistical significance not yet reached.
European Commission approves AbbVie's epcoritamab plus R2 for relapsed follicular lymphoma. Key implications for biologics manufacturing, cold-chain, and pharmacovigilance.
Wyeth's XYNTHA remains active in the FDA biologics registry. Key comparability reference for recombinant Factor VIII biosimilar and reformulation programs under ICH Q10.
Takeda's GLASSIA BLA STN 125325 shows two FDA approval actions in 2022-2023. A reference case for biologics license maintenance and post-approval supplement strategy.
FDA updated NUWIQ approval docs in December 2024 under STN BL 125555. Key compliance reference for recombinant Factor VIII manufacturers under GMP and ICH Q10.
FDA approved a Pentacel package insert revision on March 12, 2026, correcting the IPV analytical method description. Key implications for QA and regulatory teams.
FDA issued a March 2026 approval letter for Sanofi Pasteur's Quadracel DTaP-IPV pediatric vaccine. QA and regulatory teams should review document control implications.
Sanofi Pasteur's DENGVAXIA has four FDA approval letters from 2019–2023. A reference case for biologics manufacturers on post-approval safety commitments and label revisions.
Baxter's Advate plasma/albumin-free Factor VIII method set a GMP precedent for recombinant biologics. Key lessons for QA directors and regulatory affairs leads.
FDA updated remdesivir EUA fact sheets after non-clinical data flagged reduced antiviral activity with chloroquine co-administration. Key read for regulatory affairs teams.
FDA's March 2026 approval letter for MSP Vaccine Company's VAXELIS hexavalent vaccine highlights ongoing post-approval complexity for multi-antigen biologics manufacturers.
FDA's 2020 remdesivir EUA sets a key precedent for GMP compliance, dossier structure, and benefit-risk thresholds under emergency authorization pathways.
FDA's EUA for Gohibic (vilobelimab) IV injection sets sterile injectable, labeling, and post-authorization safety monitoring benchmarks for COVID-19 critical care.
FDA's full approval of Veklury (remdesivir) for COVID-19 sets a regulatory precedent for EUA-to-approval transitions. Key implications for QA and regulatory affairs leads.
REGENXBIO doses first patient in pivotal NAAVIGATE trial of surabgene lomparvovec, triggering a $100M AbbVie milestone. Key GMP and ATMP manufacturing implications.
Teva moves TEV-'408 into Phase 2b vitiligo development in Q4 2026 after Phase 1b data. Quarterly subcutaneous dosing design raises formulation and fill-finish planning questions.
Aquestive Therapeutics joins Leerink Partners' I&I and Metabolism Forum on July 14. Key CDMO and PharmFilm® oral film platform implications for QA and regulatory leads.
AbbVie's TEPKINLY receives EMA approval for relapsed/refractory follicular lymphoma. Key implications for biologics manufacturing scale-up, GMP compliance, and EU market access.
Propanc Biopharma partners with Avance Clinical for a Phase 1b First-in-Human oncology trial of PRP, leveraging Australia's R&D tax rebate and FDA Project Optimus-aligned design.
Eupraxia Pharmaceuticals adds Robert Bazemore, Amy Pott, and Dr. Helen Thackray to its board as EP-104GI advances toward late-stage development milestones.
FDA clarifies MIDD Paired Meeting Program rules: open at any IND stage, Type C confidentiality protections, and sponsor-led modeling requirements explained.
FDA's June 2026 ICH M15 MIDD guidance raises documentation standards for IND packages. What regulatory and QA teams must address before the next quarterly deadline.
EMA's CHMP opens phased review of Revolution Medicines' daraxonrasib for metastatic pancreatic cancer, setting a template for EU submission strategy under reformed legislation.
Celea Therapeutics secures $180M to launch SURPASS-IPF, the first head-to-head Phase 3 IPF trial. Key implications for CMOs and clinical supply chains in Q3 2026.
Realbotix, Onconetix's pending acquisition target, partners with Bloom Procurement Services to pilot humanoid robots in UK elderly care settings ahead of 2026 deal close.
Jupiter Neurosciences adds former White House Council of Economic Advisers Acting Chairman Dr. Tomas Philipson to its board, effective June 26, 2026.
FDA grants accelerated approval for Trutakna (atacicept-vymj) in IgA nephropathy. Confirmatory trial required. Key implications for regulatory and QA teams.
FDA's final guidance on food effect studies sets a tiered framework for oral drug IND and NDA programs, covering pilot assessments, pivotal trial sequencing, and prescribing information.
WHO confirms falsified DARZALEX detected in Maldives and Mexico. QA and supply chain teams should review serialization controls and supplier qualification records.
MHRA approves Wegovy for MASH in obesity and diabetes patients. QA and regulatory leads face CMC update obligations and supply capacity challenges across semaglutide's expanded label.
Newron Pharmaceuticals completes FDA Type A meeting on ENIGMA-TRS 2 clinical hold. Learn what the required changes mean for U.S. trial restart under 21 CFR Part 312.
Brii Bio secures preliminary CDE alignment for a hepatitis B registrational study after mixed phase 2b results. Key lessons for sponsors targeting China's NMPA pathway.
Novartis's $1.5B Myricx Bio acquisition adds NMTi ADC payloads to its oncology pipeline. What plant heads and QA directors need to anticipate in manufacturing.
Shilpa Biologicals and Orion partner to bring a nivolumab biosimilar to Europe. Key EMA regulatory and GMP implications for biosimilar developers targeting the EU market.
Glenmark Pharmaceuticals launches Olanzapine for Injection in the US, achieving therapeutic equivalence to Zyprexa IM. Key implications for injectable GMP and regulatory strategy.
Serum Institute advances dengue candidate into Phase III trials in Brazil, Malaysia, and Thailand following DNDi licensing deal. GMP and supply chain implications for manufacturers.
Longeveron names Marie Washburn CFO ahead of Phase 2b laromestrocel results for HLHS, a rare pediatric heart defect, expected Q3 2026.
Levicept names Deptula-Hicks CFO to advance LEVI-04 non-opioid OA therapy after Phase II showed significant pain relief in 500+ patients.
ImageneBio names Matt Robbins General Counsel to lead legal strategy as IMG-007 enters Phase II trials for atopic dermatitis and alopecia areata.
Kymera appoints Dr. Laws as SVP to advance KT-621 STAT6 degrader through Phase IIb trials in atopic dermatitis and asthma toward registration.
Akari Therapeutics adds Dr. Patricia LoRusso to its SAB as AKTX-101, a TROP2-targeting ADC with RNA splicing payload, heads toward Phase I trials in mid-2027.
Stipple Bio appoints Roland Gendron as CBO to lead partnerships and pipeline strategy as STP-100 targets clinical entry following a $100M Series A raise.
3PBIOVIAN outlines how early process design decisions in AAV and adenovirus manufacturing determine GMP success at commercial scale. Key read for gene therapy QA leads.
60 Degrees Pharmaceuticals signs exclusive option with Florida State University for castanospermine tick-borne disease IP, pivoting from NDI to prescription drug pathway.
Taro Pharmaceutical launches AB-rated perampanel 0.5 mg/mL oral suspension, generic to Fycompa. Key implications for formulary substitution and 503B compounding.
Otsuka's VOYXACT gains FDA accelerated approval for IgAN using proteinuria as a surrogate endpoint. Key precedent for RA and QA teams tracking biologic submissions.
Tarsus Pharmaceuticals acquires iRenix Medical and IRX-101, an FDA-aligned Phase 3 ocular antiseptic with Phase 2b/3 data in intravitreal injection procedures.
FDA approves Roche's Elecsys HBsAg II and Auto Confirm for HBsAg donor screening under 21 CFR Part 610. Key compliance steps for blood establishments and plasma manufacturers.
FDA approved a supplemental BLA for Octapharma's FIBRYGA fibrinogen concentrate on June 23, 2025, expanding its label to acquired fibrinogen deficiency under 21 CFR Part 640.
FDA's CTGT Advisory Committee reviews Replimune's vusolimogene oderparepvec BLA on July 30, 2026. Public comment docket FDA-2026-N-7231 closes July 29.
FDA's final rule mandates a uniform 12-digit NDC by March 2033. Key steps for manufacturers on labeling updates, DSCSA barcodes, and system readiness.
Biocon releases two peer-reviewed Phase III INSIGHT studies for Yesafili aflibercept biosimilar, covering switch safety and DME subgroup data ahead of U.S. launch.
Roche's Elecsys IGRA TB test gains CE Mark, offering 19-minute automated latent TB detection on cobas immunoassay systems. Key read for QA and lab operations leads.
Ipsen's Dysport meets Phase III endpoints in both episodic and chronic migraine. What QA and manufacturing teams should anticipate ahead of regulatory submission.
Aura Biosciences appoints biotech veteran Jeremy Bender to its Board, bringing deep expertise in oncology strategy and commercialisation.
Tarsus acquires iRenix Medical and IRX-101, aiming to improve patient comfort and reduce corneal damage during intravitreal therapy.
Chemomab and Scipher merge to advance nebokitug in rheumatoid arthritis, backed by $30 million in new financing.
Aspen Neuroscience completes ASPIRO Cohorts 3 and 4 dosing using a cryopreserved sasineprocel formulation, raising key ICH Q5C comparability questions ahead of Phase 3.
EMA clears commercial GP2 lot for FLAMINGO-01, aligning with FDA approval. All US and European sites now use the same lot; UK and Canada submissions ongoing.
Novo Nordisk launches Awiqli in India, the world's first once-weekly basal insulin. Key implications for cold chain, fill-finish validation, and CDSCO compliance.
Teva and Polpharma Biologics formalize a global licensing deal for an ocrelizumab biosimilar, splitting CMC and regulatory roles across eight markets.
FibroBiologics appoints retired NASA astronaut and microbiologist Kate Rubins, Ph.D. to its Board of Directors, strengthening scientific oversight of its fibroblast cell therapy pipeline.
WHO's 2026 cancer report projects 35 million annual cases by 2050. Read the oncology manufacturing, cytotoxic containment, and regulatory capacity implications.
FDA revised eCTD v4.0 standards on July 9, 2026, updating Regional CV Package, Transmission Specifications v2.0, and adding Forward Compatibility XML Samples for CDER and CBER filers.
FDA released Transmission Specifications v2.0 for eCTD v3.2.2 on July 9, 2026. Regulatory teams must align submission tooling to avoid CDER and CBER validation failures.
Reagan-Udall Foundation and FDA convene August 5, 2026 hybrid meeting on drug repurposing selection criteria. Public comment deadline July 21, 2026.
FDA draft guidance sets a ~50 bp threshold requiring long-read sequencing for genome editing safety in gene therapy. Key implications for IND/BLA submissions.
FDA's PreCheck Pilot and ANDA Prioritization programs offer expedited review for U.S.-manufactured drugs. Seven companies enrolled. Key criteria for QA and regulatory teams.
Nurix Therapeutics and Roche enter a $2.3B co-development deal for bexobrutideg across CLL, MS, and CSU. GMP and CMO capacity implications examined.