Explore the complete list of our presses below (Page 20 of 27):
Climb Bio secures FDA Fast Track for budoprutug, an anti-CD19 antibody in development for primary membranous nephropathy, addressing a major unmet medical need.
Corbus gains FDA alignment on the registration path for CRB-701 in head, neck, and cervical cancers, advancing toward late-stage clinical development.
Jupiter Neurosciences adds Kristopher Fishman and Sanjiv Lal to the Nugevia Advisory Board to strengthen strategy in the growing nutraceutical market.
Merakris shows promising MTX-001 results in venous leg ulcers, supporting progression to late-stage trials and potential future FDA approval.
Phase 2 trials show lunsekimig improves asthma and respiratory symptoms with good safety, supporting its potential as a new treatment option.
PathAI teams up with MedStar Health to deploy AI-powered digital pathology, enhancing workflow, accuracy, and diagnostics across its multi-site network
Mesoblast teams with PPMD to support enrollment in an FDA-cleared Ryoncil trial, testing its potential to slow muscle deterioration in children with DMD.
Greenwich LifeSciences files new patent claims for GLSI-100, expanding its potential use in breast cancer and doubling target patient population.
Abeona appoints Keith Goldan to its board as Audit Chair, bringing 20+ years of biotech financial leadership to support strategic growth.
Outlook Therapeutics files a dispute request with the FDA for ONS-5010, aiming to advance approval for an AMD treatment after a prior CRL setback.
Amneal donates $2M to support Parkinson’s patients, improving access to treatment, financial aid, and community awareness during Parkinson’s Awareness Month.
Merck launches tender offer to acquire Terns Pharmaceuticals at $53 per share, with the deal expected to close in Q2 2026, pending approvals.
Plus Therapeutics secures AMA CPT code for CNSide CSF test, supporting reimbursement, adoption, and tracking in CNS cancer diagnostics.
ANI publishes NEW DAY trial results for ILUVIEN in DME, highlighting efficacy and safety risks including cataracts and increased intraocular pressure.
GRI Bio receives a UAE Notice of Allowance for patent covering novel type 2 dNKT cell agonists for inflammatory conditions, strengthening its global IP strategy.
Longeveron secures a new Chinese patent protecting potency assay methods for evaluating mesenchymal stem cells, extending its IP coverage through 2041.
Spectral AI names David McGuire as CFO to strengthen financial leadership ahead of DeepView commercialization and support long-term growth.
RenovoRx receives its first Japanese patent allowance, strengthening protection for the RenovoCath device and its targeted drug-delivery approach.
Remedy Plan Therapeutics appoints Jotin Marango as CFO & CBO to drive financial strategy, growth, and advancement of its clinical oncology initiatives.
Psyence BioMed grows its Australian network from three to five sites to support its ongoing Phase IIb trial of natural psilocybin for Adjustment Disorder.
FDA lifts partial hold on MacroGenics, Inc. Phase 2 LINNET trial, allowing enrollment to resume under an updated safety protocol.
Precision Neuroscience appoints Craig Mermel as Chief AI and Data Officer to lead AI strategy and development of its high-resolution neural dataset.
Kali Therapeutics licenses KT501 to Sanofi in a deal worth up to $1.05B, advancing a tri-specific antibody for autoimmune disease treatment.
GSK’s Exdensur gains China approval for CRSwNP, showing strong Phase III results and offering long-acting relief for patients with uncontrolled disease.
Alkem launches A to Z Daily multivitamin with 26 nutrients and botanicals, supporting energy, immunity, and mental wellness for daily use.
Nxera achieves milestone in Lilly partnership for diabetes drug discovery, advancing GPCR-targeted research and unlocking potential milestone payments.
Telix appoints Maria Rivas and Bill Jellison as Non-Executive Directors to strengthen board leadership and support growth strategy.
Cue Biopharma earns $7.5M milestone from Boehringer Ingelheim, advancing T cell-based therapies targeting autoimmune diseases
FDA grants Orphan Drug status to Plus Therapeutics’ REYOBIQ for pediatric gliomas, supporting development of treatments for rare brain cancers.
ANI launches generic Isosorbide Mononitrate tablets after FDA approval, expanding access to affordable angina treatment options.
Glenmark receives US FDA approval for Progesterone Vaginal Inserts, a generic of Endometrin, targeting a $59.2 million U.S. market segment.
Telix’s Pixclara NDA accepted by US FDA with a PDUFA date of Sept 11, 2026, advancing a PET imaging agent for improved glioma diagnosis.
Amneal launches generic bimatoprost ophthalmic solution 0.01%, equivalent to Lumigan, targeting a $719 million U.S. glaucoma treatment market.
Plus Therapeutics appoints Eric J. Daniels as Chief Development Officer, strengthening leadership with 20+ years of biotech and clinical development expertise.
Zenyaku Kogyo to take full control of Rituxan sales in Japan after ending co-promotion with Chugai Pharmaceutical from September 2026.
EMA now allows Wegovy injection storage at up to 30°C for 48 hours during delivery, easing cold-chain logistics across Europe.
Novartis expands global programs to improve heart disease and cancer care access, aiming to reach over 30 countries by 2030 with community health initiatives.
Zentalis selects 400mg dose of azenosertib after DENALI results, advancing it toward Phase 3 and potential approval in ovarian cancer treatment
Idorsia names Dr. Amer Joseph as EVP, CMO & Head of Global Clinical Development, succeeding Dr. Alberto Gimona as the company advances its scientific strategy.
Decoy Therapeutics reports major scientific and corporate progress as it advances its multi-antiviral platform toward clinical development
Charles River and the AHA partner to boost national heart-health awareness, prevention efforts and community programs to reduce cardiovascular disease
BioXcel Therapeutics enrolls first patients in DoW-funded Phase 2a trial of BXCL501 for acute stress reactions in collaboration with UNC.
Aravax adds Carsten Hellmann and Andrew Oxtoby to its Board, bringing deep allergy therapeutics expertise to advance its peanut allergy program PVX108.
Thermo Fisher and PRECISE partner to advance SG100K, a major population-scale proteomics study aimed at improving disease insights and precision health.
European Commission approves Dupixent for children 2–11 with chronic spontaneous urticaria, expanding treatment options for uncontrolled CSU.
Nxera Pharma earns $22.5M milestone as Neurocrine starts Phase 2 trial of NBI-1117570 for schizophrenia, advancing new treatment research.
Roche’s Elecsys NfL blood test wins CE mark to detect neuroinflammation in RRMS, enabling easier monitoring of multiple sclerosis disease activity.
NRx Pharmaceuticals appoints Glenn Tyson as its first CCO as it readies key ketamine programs & strengthens commercial strategy for upcoming psychiatric therapies
Oragenics doses the first patient in its Phase IIa trial of ONP-002, an intranasal therapy that aims to become the first drug treatment for concussion and mTBI.
Regeneron & Telix form a partnership to develop next-gen radiopharmaceutical cancer therapies, combining antibody expertise with advanced radiopharma capabilities.
Spyre Therapeutics reports positive 12-week Phase 2 SKYLINE data for SPY001, showing strong potential as a best-in-class treatment for moderate-to-severe UC.
ALX Oncology appoints Jeff Knight as Chief Development and Operating Officer to lead clinical development and support upcoming oncology program milestones.
Epitopea adds expert Lisa Butterfield to its Scientific Advisory Board as it advances RNA-based cancer therapies, including its lead program CryptiVax-1001.
Kymera Therapeutics receives FDA Fast Track designation for KT-621, an oral STAT6 degrader in Phase 2b trials for moderate to severe eosinophilic asthma.
Geron appoints Timothy Williams as EVP, Chief Legal Officer, & Corporate Secretary, adding key legal & leadership expertise to support its hematology strategy.
Enhanced Compliance Inc appoints Khalid Raja as SVP to drive strategic growth, bringing 30+ years of quality and regulatory leadership in life sciences.
GSK reports strong Phase I results for Mo-Rez ADC, showing up to 67% response in ovarian and endometrial cancers, advancing to Phase III trials.
Neuronetics expands access to TMS therapy as Optum updates policy allowing nurse practitioners to deliver NeuroStar treatment for depression.
Thermo Fisher partners with HealthVerity to access 270M patient data, enhancing AI-driven clinical trials and real-world evidence generation.
FDA grants Priority Review to Daiichi Sankyo and Merck’s lung cancer drug ifinatamab deruxtecan, with decision expected by October 2026.
Enanta doses first patient in Phase 1 trial of EDP-978, an oral KIT inhibitor for urticaria, evaluating safety, PK, and PD in healthy volunteers.
ANI Pharmaceuticals launches generic carbamazepine extended-release capsules, targeting a $65 million U.S. market for neurological treatments.
IDEAYA and Servier report strong Phase 2/3 results for darovasertib combo in uveal melanoma, showing improved PFS and response rates.
Novo Nordisk partners with OpenAI to use AI in drug discovery, manufacturing, and operations, aiming to accelerate innovation and improve patient outcomes.
FDA warns Dry Springs Pharmacy over unapproved, misbranded online drug sales. What manufacturers and compounders must know about compliance.
Sun Pharma's 116-product generic pipeline and API growth raise manufacturing capacity and USFDA compliance questions for the industry.
Hormuz corridor tensions drive up pharma raw material costs. Indian MSMEs face price spikes on key inputs. What plant heads and QA teams need to know.
Structure Therapeutics Inc. appoints Matthew Lang as COO to support aleniglipron obesity drug as it moves into Phase 3 trials.
Telix Pharmaceuticals Limited doses first patient with TLX101-Tx for recurrent glioblastoma in Phase 3 IPAX BrIGHT trial.
Tempest Therapeutics, Inc. appoints Andrew Fang to drive amezalpat hepatocellular carcinoma partnerships and support China Phase 3 expansion.
Zealand Pharma A/S appoints Eric Rojas as VP of Investor Relations to support pipeline growth and U.S. expansion strategy.
Rivus Pharmaceuticals Inc. begins HU6 Phase 2 AMPLIFY trial dosing for MASH to evaluate liver fat reduction and metabolic outcomes.
Culture Biosciences appoints Mike Stapleton to Board to scale Stratyx hardware and Console SaaS platform for bioprocess development.
Neion Bio appoints James Kehler as Head of Avian Sciences to advance genome engineering for biologics production.
Sandoz signs deal with Rwanda to supply essential medicines and antibiotics, expanding access across African countries.
Aligos Therapeutics reports Phase 2 data and gains FDA Fast Track for pevifoscorvir in chronic hepatitis B.
Amneal Pharmaceuticals launches generic albuterol and beclomethasone inhalers in the U.S. for asthma and bronchospasm treatment.
Praxis Precision Medicines gains FDA NDA acceptance for ulixacaltamide in essential tremor with PDUFA decision in January 2027.
Avantor, Inc. signs exclusive deal to distribute Parafilm M in India, expanding lab sealing and contamination control solutions.
Nxera Pharma gains Taiwan approval for QUVIVIQ insomnia drug through partner Holling Bio-Pharma, with launch planned in 2026.
Clearmind Medicine moves CMND-100 into cohort 4 for alcohol use disorder after positive Phase I/IIa safety review with no serious adverse events reported.
NeuraClick appoints Dr. Gavin Dawe and Dr. Tomi Sawyer to support neuropeptide platform and CNS drug development strategy.
Neutrolis appoints Caren Deardorf as Chief Business and Strategy Officer to drive pipeline strategy and growth in autoimmune and inflammatory disease programs.
Nkarta gains FDA alignment to expand NKX019 trials, enabling outpatient dosing and broader patient access in autoimmune disease studies.
Tango Therapeutics adds leadership to advance vopimetostat for pancreatic cancer and support late-stage development and potential approval.
ARS Pharmaceuticals wins Health Canada approval for neffy to treat anaphylaxis, expanding needle-free emergency allergy care in Canada.
Prelude Therapeutics appoints Charles Morris as Chief Medical Officer to lead oncology pipeline and clinical development strategy.
Plus Therapeutics appoints Randy Goodman as VP HEOR to lead value strategy and market access for CNS oncology portfolio including CNSide and REYOBIQ.
Achieve Life Sciences advances cytisinicline manufacturing with Adare and plans NDA resubmission in 2026 for nicotine dependence treatment.
Dogwood Therapeutics gains FDA IND approval for SP16 to treat chemotherapy-induced neuropathy and plans Phase 1b trial in 2026.
Medix Biochemica appoints Petra Furu as CEO to lead growth strategy and expand its IVD business globally.
FDA warns ybycmeds for misbranding compounded semaglutide and tirzepatide products. Section 502 violations cited for claims of similarity to Ozempic and Mounjaro.
FDA warns Tuyo Health over misleading compounded semaglutide and tirzepatide claims. What 503A/503B compounders need to know about FDCA 502(a) compliance.
FDA warning letter to Sprout Health cites misbranding of compounded semaglutide and tirzepatide. What compounding QA teams need to know now.
FDA's FAERS upgrade to ICH E2B(R3) standards requires pharma teams to update ICSR submission systems. Review draft business rules and technical specs.
Cochrane Collaboration review finds amyloid-targeting Alzheimer's therapies lack meaningful clinical benefit, raising FDA/EMA regulatory implications.
FDA clears Alembic Pharmaceuticals' ANDA for Methotrexate Injection. Analysis of sterile injectable compliance, ANDA review timelines, and supply impact.
UAlbany develops laser-based non-destructive method for mRNA vaccine characterization with potential GMP release testing applications.
NPA survey reveals fake weight-loss injections reached UK consumers. What GMP manufacturers and QA teams need to know about serialization and supply chain gaps.
Cumberland Pharmaceuticals wins expanded FDA indication for Caldolor IV ibuprofen. What hospital formulary and QA teams need to know about the label change.
Aerska appoints Stuart Milstein to advance RNAi platform for CNS diseases toward clinical development.
Arbutus Biopharma Corporation wins FDA Fast Track for imdusiran in chronic hepatitis B, aiming to speed development of this investigational therapy.
Immutep Limited gains FDA Orphan Drug status for eftilagimod alfa in soft tissue sarcoma, supporting its immunotherapy development in rare cancer.
MinervaX ApS appoints new leaders to advance its GBS vaccine into late-stage trials for preventing Group B Streptococcus infections.
PacBio and Covaris launch FFPE workflow for HiFi cancer sequencing, improving variant detection from archived tissue samples.
FDA generic drug review times fell from 35.93 to 32.82 months in FY 2026. First-cycle approvals reached 80 through April. Analysis for generic manufacturers.
Medera's FDA Fast Track for low-dose AAV-SERCA2a gene therapy in DMD cardiomyopathy raises CMO batch release and potency assay readiness questions.
Achieve Life Sciences appoints Andrew Goldberg, MD, as CEO with $354M financing ahead of potential FDA approval of cytisinicline for nicotine dependence.
Xilio Therapeutics presents preclinical data for XTX601, a masked T cell engager targeting CLDN18.2, showing tumor-selective activation and NHP tolerability.
ARS Pharma's neffy approval highlights GMP manufacturing and 505(b)(2) regulatory challenges for drug delivery reformulations targeting line extensions.
Merck shares PD-1xVEGF bispecific data in NSCLC but holds back on phase 3 plans. What this means for GMP manufacturing and facility investment.
Oral biologics and macrocycle drugs from J&J and Merck are reshaping pharma manufacturing. What plant heads and QA directors need to know.
Sanofi's COMPARE study shows Nuvaxovid has statistically lower reactogenicity than Moderna's mNEXSPIKE across all endpoints in 1,000 US adults.
Aurobindo Pharma gets USFDA nod for Glycerol Phenylbutyrate Oral Liquid, a generic Ravicti for urea cycle disorders. Impact on pricing and supply.
PGI Chandigarh resumes bariatric surgery in 2025 with three sleeve gastrectomies after zero cases in 2024, as weight-loss injections reshape obesity care.
Updated zongertinib trial data in frontline HER2-mutated NSCLC signal manufacturing scale-up, process validation, and GMP readiness demands.
Ministry of Health and OECS host antimicrobial stewardship workshop to strengthen responsible medicine use across the Eastern Caribbean region.
Health Canada approved Biocon's Bosaya and Vevzuo denosumab biosimilars on April 3, 2026, covering osteoporosis and oncology bone indications across two dosing presentations.
BioMed X establishes an AI-driven bispecific antibody research team in France under immunologist Tomabu Adjobimey, signaling a shift in biologics discovery strategy.
Allogene publishes preclinical data on an allogeneic BCMA/CD70 dual CAR T program for high-risk multiple myeloma. Key implications for GMP manufacturing and regulatory strategy.
FDA accepts Roche's sBLA for obinutuzumab (Gazyva) in SLE based on ALLEGORY phase III data. Decision expected December 2026. Key GMP and regulatory implications.
Eli Lilly's $7B acquisition of Kelonia Therapeutics signals a shift in ATMP manufacturing strategy with major implications for CDMOs and in vivo CAR-T GMP.
Merck's pumitamig update at AACR 2026 re-enters the PD-pathway race. What it means for CMC, process validation, and late-stage oncology manufacturing strategy.
CDSCO replaces approval requirements for early drug testing with a digital prior intimation system on the NSWS portal. Key implications for pharma and CDMOs.
Eupraxia's EP-104GI shows 90% tissue score reduction and 66% remission at 36 weeks in EoE highest dose cohort. No drug-related SAEs across 31 patients.
Eli Lilly CEO David Ricks frames GLP-1 drugs as a statin-scale opportunity. Here is what the demand debate means for manufacturing capacity and supply chain planning.
Proposed Pharmaceutical Affairs Act revisions in Asia would extend government supply authority to nonessential drugs. Public comment closes June 10. Key implications for multinational pharma.
Galux and GC Biopharma partner on AI antibody drug discovery. What it means for GMP manufacturers, QA directors, and regulatory affairs teams preparing for novel biologics.
Isosceles Pharmaceuticals doses first patient in IPI201 Phase I trial. What QA and CMC teams need to know about manufacturing readiness implications.
The MHRA has recalled a Ramipril batch due to a manufacturing error. QA directors should review batch release controls and deviation management processes now.
Allogene expands its Phase 2 ALPHA3 trial to South Korea and Australia, raising key questions about allogeneic cell therapy CMC readiness and BLA filing strategy.
FDA's OGD has redesigned GDUFA III pre-submission meetings to reduce ANDA risk. Learn what changed, who is affected, and how to prepare a meeting request.
Roche's fenebrutinib reduced MS relapse rates by up to 58.5% vs teriflunomide in Phase III. A combined RMS and PPMS regulatory submission is now confirmed.
FDA opens PreCheck Pilot applications February 1, 2026. Learn how early GMP facility assessments will reshape domestic manufacturing timelines and inspection strategy.
ProBioGen names Dr. Simon Johannes Bulling COO. His dual drug substance and drug product background has direct implications for CDMO GMP and process validation.
FDA's SrLC database tracks NDA and BLA safety labeling changes since 2016. Learn how regulatory affairs teams can use it for proactive postmarket compliance.
FDA grants priority review approval for Sanofi's Tzield sBLA, expanding the pediatric T1D indication to children as young as one year, backed by phase 4 PK data.
FDA extends Sarclisa SC BLA review up to three months to July 23, 2026. The on-body injector filing signals growing regulatory complexity for oncology combination products.
Ipsen's tovorafenib receives EU conditional marketing authorization as the first targeted therapy for relapsed or refractory pLGG, based on Phase II FIREFLY-1 data.
Asahi Kasei completes Aicuris acquisition to build a global specialty pharma platform focused on severe infectious diseases. GMP and regulatory implications examined.
Merck wins FDA priority review for KEYTRUDA and KEYTRUDA QLEX plus Padcev in bladder cancer. Key implications for biologics manufacturing and GMP compliance.
Leinco and CellCarta partner on integrated proteomics for biomarker discovery in oncology. What it means for analytical testing and GMP compliance in drug development.
Supriya Lifescience receives USFDA EIR with VAI classification for its Maharashtra API facility, maintaining GMP compliance and U.S. market supply eligibility.
Adial Pharmaceuticals confirms AD04 demonstration batch met dissolution, blend, and content uniformity specs, enabling Phase 3 clinical and registration production.
Capricor's HOPE-3 Phase 3 DMD results presented at AAN 2026. With a PDUFA date of August 22, 2026, allogeneic CDC manufacturing and CDMO capacity face new scrutiny.
Moderna's EU approval for the first combined flu/COVID mRNA vaccine sets a CMC and batch release benchmark for manufacturers developing combination vaccine pipelines.
AstraZeneca's Ultomiris posts strong Phase III interim results in IgA nephropathy. What this means for complement inhibitor manufacturing capacity and GMP planning.
Roche's ENSPRYNG cuts MOGAD relapse risk 68% in Phase III METEOROID trial. QA and regulatory teams should prepare for BLA/MAA filings and CMC requirements.
AbbVie's $1.4B Durham, NC campus will anchor U.S. SVP sterile injectable manufacturing with AI-integrated GMP operations. Construction starts 2026, completion 2028.
George Medicines' TRIDENT trial shows GMRx2 fixed-dose triple combination reduced recurrent stroke by 39% in ICH survivors. NEJM publication, April 2026.
Inventiva appoints CFO, CLO, and CPO ahead of NATiV3 Phase 3 lanifibranor data in Q4 2026, signaling regulatory and commercial readiness in the MASH pipeline.
FDA approves Dupixent for CSU in children aged 2-11 via efficacy extrapolation and PK bridging. A regulatory pathway model for future pediatric biologic submissions.
FDA's GDUFA III DMF prior assessment process allows Type II API DMF holders to request review 6 months before ANDA submission. Key details for regulatory teams.
Orion Pharma initiates TEADCO Phase 1b/2 basket trial evaluating ODM-212 pan-TEAD inhibitor in mesothelioma, KRAS G12C NSCLC, and pancreatic cancer combinations.
Sanofi's Q1 2026 results include five immunology approvals, Dupixent at €4.2B, and the Dynavax close. Here's what it means for manufacturing and GMP compliance.
Roche's Q1 2026 Phase III fenebrutinib and Phase II petrelintide data advance toward commercial scale, pressing CMOs on process validation and supply readiness.
Ipsen withdraws Tazverik on safety signals, posts 22.6% CER sales growth in Q1 2026, and targets three Phase III readouts in H2 2026. Key implications for QA and manufacturing.
Plus Therapeutics activates SpectronRx as a second GMP site for REYOBIQ, advancing a dual-site radiopharmaceutical supply chain ahead of pivotal trials.
Novo Nordisk's PIONEER TEENS Phase 3a trial meets primary endpoint in youth aged 10-17. US and EU label expansion filings for oral semaglutide planned H2 2026.
Greenwich LifeSciences FLAMINGO-01 interim data shows 70-80% recurrence reduction. What do CMC and process validation teams need to know about GLSI-100 scale-up?
WHO certifies the Bahamas for eliminating mother-to-child HIV transmission, meeting strict antenatal coverage and transmission rate thresholds under its MCH programme.
WHO's 2025 Results Report shows Triple Billion progress but flags funding constraints, missed output indicators, and SDG timelines at risk by 2030.
Regeneron's White House agreement links Medicaid and future U.S. drug prices to developed-country benchmarks, with Otarmeni gene therapy offered free domestically.
Regeneron's Otarmeni receives FDA accelerated approval as the first gene therapy for OTOF-related hearing loss, with 80% of CHORD trial participants meeting the primary endpoint.
Dogwood Therapeutics transfers antiviral assets IMC-1 and IMC-2 to PRIDCor Therapeutics in a deal capped at $100M, refocusing on Halneuron and SP16 for pain.
PridCor Therapeutics acquires Phase 3-ready IMC-1 and Phase 2b-ready IMC-2, targeting Long COVID and infection-associated chronic illness via viral reactivation.
J&J's 120-week nipocalimab OLE data in gMG shows sustained IgG reduction and symptom control, with regulatory and lifecycle management implications for FcRn blockers.
Lupin enters the US generic SGLT2 market with FDA-approved Dapagliflozin/Metformin ER Tablets, bioequivalent to AstraZeneca's Xigduo XR. Key implications for generics manufacturers.
Neuland Laboratories reports rising peptide engagements from Japanese pharma at preclinical stages, signalling a structural shift in CDMO outsourcing strategy.
CDER approved 46 novel drugs in 2025 across oncology, rare disease, and biologics. Here is what CDMOs and QA directors need to know about manufacturing and GMP implications.
FDA's Drug Trials Snapshots program documents trial demographics for NMEs and biologics. What QA and regulatory teams must monitor in new approval packages.
FDA approved Entasis Therapeutics' NUZOLVENCE (zoliflodacin) for gonorrhea in Dec. 2025 via a single Phase 3 trial. Key implications for anti-infective regulatory strategy.
FDA approves Regeneron's Otarmeni under CNPV in 61 days, the first dual-vector AAV gene therapy cleared via the pilot. Key implications for BLA and CMC strategy.
CLINUVEL receives final EMA scientific advice for its pivotal Phase III vitiligo study. Key implications for regulatory affairs teams planning pivotal trial design.
Clariant extends continuous strip desiccant reel production to the Americas. QA teams must evaluate GMP supplier qualification implications for pharma packagers.
Novo Nordisk's oral semaglutide shows superior HbA1c reduction in pediatric type 2 diabetes. What plant heads and CMOs must prepare for now.
Novartis secures WHO prequalification for Coartem Baby, the first artemether-lumefantrine formulation for infants 2-5 kg, opening public sector procurement pathways.
Health Canada approves Biocon's Bosaya and Vevzuo as denosumab biosimilars to Prolia and Xgeva, with implications for GMP, biosimilar market access, and regulatory strategy.
EMA's CHMP recommended five medicines in April 2026, including a gene therapy for SMA and a biosimilar for eye disease, plus nine indication extensions.
EMA's CHMP recommends EU approval for plozasiran (Redemplo) in FCS without genetic testing requirement. Key implications for rare disease regulatory strategy.
Gujarat Themis Biosyn acquires 13 Sanofi anti-TB and anti-infective brands across 55+ markets for EUR 158M, triggering complex GMP and regulatory transfer obligations.
CHMP backs Novartis Itvisma for SMA patients aged 2 and older. Fixed-dose intrathecal gene therapy raises GMP and CMC strategy questions ahead of EC decision.
Sanofi's Cenrifki receives CHMP positive opinion for non-relapsing SPMS. DILI risk flags strict liver monitoring requirements for EU regulatory and QA teams.
Merck's $1B agentic AI deal with Google Cloud spans manufacturing and R&D. QA and regulatory teams must now address GMP validation and data integrity implications.
ModeX doses first patients with MDX2003 T-cell engager for B-cell lymphoma, raising CMC, process validation, and regulatory complexity for multi-specific biologics.
WHO validates Algeria as trachoma-free, the 29th country globally. Learn how the SAFE strategy and national health infrastructure drove elimination.
WHO, Gavi, and UNICEF confirm 100M+ BCU doses across 36 countries. What it means for cold chain capacity, fill-finish demand, and vaccine procurement forecasting.
Roche reaffirms $50B US manufacturing buildout as franc headwinds bite. What European pharma's onshoring wave means for GMP sites, FDA timelines, and US capacity.
Moldova's medicines agency withdraws levamisole products including Decaris following an EU-level safety reassessment linking the anthelmintic to leukoencephalopathy.
Merck's bio-based HPLC solvent portfolio claims 25.9% CO2e reduction with no method revalidation. What QA and procurement teams need to evaluate before switching.
Regeneron's Otarmeni receives FDA accelerated approval for OTOF hearing loss. What the AAV gene therapy approval means for CGT manufacturers and QA teams.
Japanese pharma companies are engaging CDMOs at preclinical stages as peptide complexity, PMDA regulatory demands, and raw material constraints strain in-house capabilities.
IPC formalises MoUs with PMBI and NIPER Hajipur to strengthen drug quality, pharmacovigilance, and research. Key implications for Indian market suppliers.
Boehringer Ingelheim India and NIPER Hajipur sign an MoU to advance translational pharma research via the opnMe platform. Key implications for Indian R&D talent.
Siegfried adds three small-molecule drug substance sites in the US and Australia to its global CDMO network from May 1, reshaping outsourcing and capacity planning decisions.
Eton Pharmaceuticals appoints Judith M. Matthews as CFO. The specialty pharma firm signals continued investment in pipeline development and regulatory strategy.
Dozens of MPs oppose Wes Streeting's NHS drug pricing authority expansion. What the Parliamentary pushback means for pharma market access in the UK.
Cork pharma manufacturers plan US operations to counter drug import tariffs. Key implications for FDA site transfers, GMP compliance, and supply chain strategy.
Sam Pharmaceuticals launches a WHO-standard manufacturing facility in Nigeria backed by FCMB and BoI, advancing GMP compliance and supply chain resilience.
A shortage of Pakistani medicines in Afghanistan is driving price surges and low-quality substitutions, exposing critical API sourcing risks across South and Central Asia.