Di seguito l'elenco completo dei nostri comunicati stampa (pagina 27 di 28):
AB Science closes EUR 14.2M private placement, reaching ~EUR 23M cash to advance masitinib in ALS and AB8939 in AML. Strategic plan due September 2026.
Ocumension files NCX 470 NDA with China's NMPA using the same Phase 3 dossier as the U.S. FDA submission. Key read for regulatory affairs teams managing multi-jurisdictional dossiers.
Glenmark Pharmaceuticals appoints 30-year veteran Manoj Chitnis as SVP. What the hire signals for GMP compliance and quality leadership strategy.
Biodeal Pharma secures Rs. 385 crore from RMB Capitalworks to enter CIS, Latin America, Africa, and Europe. Implications for GMP compliance and CDMO competition.
Samsung Bioepis launches OPUVIZ aflibercept pre-filled syringe biosimilar across Europe. Key GMP, EMA, and fill-finish implications for QA and regulatory teams.
Innate Pharma plans TELLOMAK-3 Phase 3 and accelerated approval filing for lacutamab in Sézary syndrome, backed by a USD 75M Sobi partnership upfront payment.
Unison Pharmaceuticals names Prasad Mahajan General Manager for quality and manufacturing, reflecting a wider trend of compliance expertise rising to GM level in Indian pharma.
Gland Pharma lands a global CDMO contract targeting $100M annually, covering oncology vials, lyophilised formulations, ampoules, and pre-filled syringes.
Innate Pharma and Sobi sign a USD 580M lacutamab licensing deal to fund TELLOMAK-3 Phase 3 in Sézary syndrome, targeting FDA accelerated approval.
ImmuPharma appoints Kymos Group as bioanalytical CRO for Kapiglucagon, completing a three-vendor outsourced stack as the company targets a 505(b)(2) US pathway.
Merck names Jayesh Parkar as Head of Excipients and Biopharma Chemicals for APAC, targeting commercial growth and stronger manufacturer partnerships across the region.
Veru enrolls 239 patients in Phase 2b PLATEAU trial of enobosarm plus semaglutide, secures Novo Nordisk clinical supply agreement. Interim data due Q1 2027.
Artelo Biosciences doses first patient in Phase 2 DREAM study of synthetic cannabinoid ART27.13 for glaucoma. Initial results expected Q4 2026.
Emergent BioSolutions warns AI and synthetic biology are outpacing biodefense GMP frameworks. Key implications for CDMOs, QA directors, and biosafety protocol leads.
Evotec and Odyssey Therapeutics partner on AI-driven autoimmune drug discovery. Milestone payments tied to validated hit series. No financial terms disclosed.
Zydus launches REVAHALE, India's first once-daily nebulised LAMA for COPD. Key GMP, CDSCO, and device-drug combination implications for QA and regulatory teams.
Ono Pharmaceutical and Mediar Therapeutics partner on antibody discovery for fibro-inflammatory diseases. Explore CMC and manufacturing implications for QA and regulatory leads.
Orion partner Tenax Therapeutics' Phase 3 LEVEL trial of oral levosimendan in PH-HFpEF missed primary endpoints. A Type C FDA meeting and EMA consultation are next.
DiaMedica's DM199 achieves statistically significant blood pressure reductions in Phase 2 preeclampsia trial, setting dose range for regulatory submissions and scale-up planning.
Gland Pharma posts Rs. 1,800 crore revenue in Q1 FY27, up 20% YoY, with PAT rising 47%. Implications for injectable capacity, CDMO growth, and GMP compliance.
DEA proposes moving dual orexin receptor antagonists from Schedule IV to Schedule V. Key compliance implications for daridorexant manufacturers and distributors.
Intensity Therapeutics restarts two paused oncology trials under FDA-reviewed and Swissmedic-approved protocol amendments. Cash position of $9.5M constrains site activation pace.
Fresenius Kabi recalled one lot of Tyenne tocilizumab 400 mg/20 mL vials after glass particles were found. QA teams should review particulate inspection SOPs now.
BC Platforms flags that AI drug development faces an evidence integrity problem, not a data volume problem, with direct implications for FDA submissions and ICH Q10 compliance.
Achieve Life Sciences targets Q4 2026 NDA resubmission for cytisinicline after a cGMP-driven CRL forced a CMO transition to Adare Pharma Solutions. FDA approval expected H1 2027.
Moody's upgrades Teva to Baa3 investment grade following Fitch's May 2026 move. Learn what improved financial flexibility means for Teva's manufacturing and biosimilar pipeline.
Amgen's planned Science and Innovation Center in Hyderabad's Genome Valley will join a seven-site global research network when it opens in 2027.
Bristol Myers Squibb commits $2.3B to a 600,000-sq-ft Houston biologics campus. Key implications for GMP design, process validation, and U.S. reshoring strategy.
Abbott and Google Health sign a multi-year deal integrating Lingo OTC CGM glucose data with AI coaching and a large-scale real-world metabolic health study.
FDA's 2026 lab retest confirms Detoxi Slim contains undeclared sibutramine. QA and regulatory leads should review third-party import controls and supplier qualification programs.
FDA's updated OTC framework and OMUFA FY2026–2030 reauthorization require regulatory affairs teams to audit nonprescription portfolios under the CARES Act monograph system.
Janssen's ICOTYDE gains FDA approval as the first oral IL-23 receptor antagonist for plaque psoriasis, shifting immunology manufacturing demand to OSD capacity.
Codexis advances ECO Synthesis siRNA manufacturing platform toward GMP facility build-out and FDA Emerging Technologies meeting in Q4 2026. Q2 revenue at $14.9M.
Eupraxia Pharmaceuticals reports Q2 2026 results with EP-104GI Phase 1b/2a data showing fibrosis improvement. Phase 3 EoE trial planned for 2027.
Genentech Distinguished Scientist Anwesha Dey is driving AI integration across oncology and cancer biology. Learn how machine learning is reshaping cancer drug discovery at Roche's US affiliate.
Bolt Biotherapeutics advances BDC-4182 ISAC to Cohort 4 at 4.0 mg/kg. Initial Phase 1/2 data due Q3 2026 with $18.1M cash runway into Q1 2027.
Aquestive Therapeutics completes human factors validation and PK studies for Anaphylm, targeting FDA NDA resubmission in Q3 2026 following January 2026 CRL.
Inhibikase Therapeutics secures FDA Orphan Drug Designation for IKT-001 in PAH, adding seven-year exclusivity and tax credits to its Phase 3 IMPROVE-PAH programme.
Mineralys Therapeutics' lorundrostat NDA is under FDA review with a December 22, 2026 PDUFA date. Key implications for QA, regulatory, and supply chain teams.
Madrigal Pharmaceuticals adds J&J R&D chief John C. Reed to its board as Rezdiffra's launch advances and a Phase 3 MASH cirrhosis trial continues.
FDA lab analysis finds undeclared phenolphthalein and yellow oleander derivatives in B. Magi weight-loss supplement, raising adulteration risks under 21 CFR Part 111.
FDA lab analysis confirms DMagic Plus weight-loss supplement contains undisclosed diclofenac and toxic oleander glycosides. QA and regulatory implications reviewed.
FDA's updated Rx-to-OTC switch list includes Rextovy naloxone (June 2026) and Differin Epiduo. Key GMP, labeling, and validation implications for manufacturers.
FDA confirmed undeclared tadalafil in Anaconda Premium 500K supplement. Learn the compliance and patient safety implications for QA and regulatory teams.
Medicus Pharma receives FDA 'Study May Proceed' for SkinJect in Gorlin Syndrome and IRB clearance for Teverelix Phase 2, while disclosing going-concern risk in Q2 2026.
Reviva Pharmaceuticals expects Q4 2026 FDA feedback on a new brilaroxazine formulation before RECOVER-2 Phase 3 enrollment and NDA submission for schizophrenia.
Zealand Pharma secures USD 100 million from Royalty Pharma for rusfertide royalty rights ahead of the Q3 2026 FDA PDUFA date. Takeda retains regulatory and commercial lead.
Atea Pharmaceuticals' C-BEYOND Phase 3 trial met non-inferiority endpoints for BEM/RZR in HCV. Key CMC and NDA implications for QA and regulatory leads.
Kura Oncology's ziftomenib hit $9.1M in Q2 net revenue, up 57%, capturing majority new patient share in R/R NPM1-m AML. KOMET-017 frontline enrollment underway.
NurExone signs binding MOU with Made Scientific for exclusive U.S. GMP exosome manufacturing. First GMP batches targeted H1 2027 from dual FDA/EU Annex 1 facility.
FDA Type A meeting confirms tabelecleucel BLA resubmission pathway via updated ALLELE trial data. Key lessons for regulatory teams navigating CRL responses on single-arm pivotal programs.
Allogene's positive ALPHA3 futility analysis for Cema-Cel in 1L LBCL raises allogeneic CAR-T manufacturing, process validation, and GMP supply chain questions.
Zealand Pharma confirms petrelintide Phase 3 initiation in H2 2026. CDMOs and plant heads face near-term scale-up and sterility assurance demands for the amylin analog.
Cellectar Biosciences targets mid-2027 NDA submission for iopofosine I 131 in Waldenström macroglobulinemia under FDA Accelerated Approval, with Phase 3 site activation underway.
Biomea Fusion doses first OPAL participant in icovamenib-semaglutide obesity combination trial. Key implications for clinical supply chain and API manufacturing teams.
Cabaletta Bio selects ElevateBio as a second CDMO for rese-cel CAR T manufacturing, building ATMP supply chain redundancy ahead of a 2H27 BLA submission.
Bioneeds India names Dr. Girish Joshi as COO as India's pharma exports hit USD 8.1 billion in Q1 FY27. Key implications for contract manufacturing and GMP oversight.
Karyopharm targets August 2026 sNDA submission for selinexor plus ruxolitinib in myelofibrosis under Accelerated Approval. FDA confirmed SVR35 as surrogate endpoint.
ProQR's AX-0810 confirms clinical target engagement for Axiomer RNA editing. Multiple program readouts expected through H1 2027 with EUR 117M cash runway to mid-2028.
FDA's November 2025 approval letter updates BioThrax labeling for post-exposure prophylaxis. Key implications for biologics QA teams and regulatory affairs leads.
AstraZeneca plans to submit CARES subgroup data for anselamimab to regulators after results showed 62% survival improvement in AL amyloidosis patients.
Eledon Pharmaceuticals completes FDA End-of-Phase 2 meeting for tegoprubart, clearing the path for a 600-patient global Phase 3 kidney transplant trial in late 2026.
Eton Pharmaceuticals gains FDA Fast Track for AMGLIDIA, files a PAS for KHINDIVI, and targets a 2027 NDA for ASN-001 as Q2 revenue surges 99% year-over-year.
FDA grants BMS accelerated approval for iberdomide in RRMM. ZENBEXUS REMS now mandatory for specialty pharmacies. Project Orbis review included Swissmedic.
FDA's CTGTAC votes 9-3 against deramiocel for Duchenne cardiomyopathy. BLA 125842 decision due August 22, 2026. Key implications for CGT BLA strategy.
Moleculin's MIRACLE trial shows Annamycin CR rates three times higher than control in AML. Full readout due Dec 2026–Feb 2027, with NDA and scale-up implications.
Gland Pharma names Deepak Sapra as CEO. Learn what the leadership change means for sterile injectable GMP compliance and global regulatory strategy.
FDA approves Lantheus's TAUKLARIFY F18 tau PET agent for Alzheimer's. Key GMP, manufacturing, and supply-chain implications for radiopharmaceutical operators.
NurExone reports MBP-positive cell increases in ExoPTEN preclinical spinal cord study, with implications for exosome CMC strategy and potency assay development.
Abbott India names Dr. Sudarshan Jain as Chairman. With 40+ years in pharma, the appointment signals potential shifts in compliance strategy and manufacturing investment.
China's NMPA accepts CanSinoBIO's NDA for Td5cp adolescent and adult pertussis vaccine. Key regulatory and manufacturing implications for pharma operators.
TCS launches an Agentic AI platform for drug development and pharmacovigilance. QA and regulatory leads should assess ICH Q10, 21 CFR Part 11, and validation requirements.
Aurobindo's Raleigh facility receives FDA VAI classification after 11 Form 483 observations. What the outcome signals for CAPA strategy at US generics sites.
Sun Pharma wins US court ruling dismissing Lipitor antitrust litigation. Key implications for Paragraph IV strategy and Indian generics manufacturers targeting the US market.
PM Modi's call for Indian pharma to reach the global top five raises hard questions about GMP compliance, FDA import alerts, and regulatory harmonization.
Sai Life Sciences elevates Maneesh Pingle to President of Discovery, reinforcing its integrated CRO/CDMO capabilities across drug discovery and development.
Telangana merges food safety and drugs control into TG SAFE. API and formulation manufacturers face tighter, unified enforcement under a single regulatory authority.
J&J's $2.58B acquisition option on Sail Biomedicines targets in vivo CAR T manufacturing, bypassing ex vivo GMP complexity. CMC implications for cell therapy teams.
US FDA approves Lupin's generic Pitolisant tablets as bioequivalent to Wakix. Key implications for QA directors and plant heads in the narcolepsy generics space.
Artelo Biosciences receives U.S. patent allowance for ART27.13's commercial formulation through 2041, with Phase 2 readouts in cancer anorexia and glaucoma due Q4 2026.
Optimus Pharma becomes the first Indian company to receive DCGI approval for Tapinarof cream 1%, an AhR agonist topical. Key implications for regulatory and QA teams.
CBER is advancing biologics regulatory alignment through ICH and APEC RHSC. QA and regulatory leads should understand how convergence reshapes multi-market compliance.
CBER stopped notarizing biologics export certificates in 2014. Regulatory teams must use BECATS for CFG applications and route apostille needs to the State Dept.
FDA reaffirms eHCTERS electronic registration obligations for HCT/P establishments under 21 CFR Part 1271, including annual December updates and 30-day amendment windows.
FDA licenses Emergent BioDefense's CYFENDUS anthrax vaccine under the Animal Rule. Key regulatory and CMC implications for biodefense biologics manufacturers.
FDA and CDC reissue VAERS guidance clarifying NCVIA mandatory reporting obligations for vaccine manufacturers, including Reportable Events Table requirements.
FDA and CDC reaffirm VAERS post-market surveillance reporting requirements for vaccine manufacturers under CBER oversight and 21 CFR Part 600.
Biocon gains FDA approval for Yesintek prefilled autoinjectors. QA and regulatory leads should note combination product, 21 CFR Part 4, and process validation implications.
Coultreon Biopharma names Prista Charuworn MD as CMO to advance SIK3 inhibitor COL-5671 into Phase II for ulcerative colitis and psoriasis. Key implications for QA and CMC teams.
Biocon gains FDA approval for Yesintek ustekinumab-kfce prefilled autoinjector. Key implications for QA, regulatory affairs, and biosimilar combination product strategy.
FDA's generative AI medical device discussion paper proposes risk and premarket frameworks. QA and RA leads in pharma should track implications before the Oct 19 comment deadline.
FibroBiologics reports preclinical cartilage repair in four weeks using FSdCS with a four-day manufacturing cycle. GMP validation and regulatory pathway remain ahead.
Propanc Biopharma initiates Phase 1b feasibility assessment for PRP in solid tumors, with Avance Clinical as CRO and a TGA CTA submission targeted for Q4 2026.
FDA's August 2026 warning letter to Safrel Pharmaceuticals cites no quality unit, no CoAs, no supplier agreements, and inadequate 483 response for OTC drug operations.
FDA issues warning letter to Tianjin Kilo after remote 704(a)(4) review finds process validation failures and drug listing violations at Chinese API facility.
Hearzap completes acquisition of Amplifon India's hearing healthcare business, expanding its clinic network and triggering operational integration across sites.
Novartis India appoints Dr. Chetan P. as Head of Medical, Regulatory and Pharmacovigilance, consolidating compliance functions amid tightening CDSCO oversight.
Novartis presents 10 cardiovascular abstracts at ESC 2026. Phase IV inclisiran and abelacimab data carry manufacturing scale-up and regulatory filing implications for biopharma facilities.
IDEAYA Biosciences will supply IDE892 into a Genentech-sponsored Phase 1 trial in MTAP-deleted PDAC. QA and supply chain implications of the joint governance model examined.
FDA CBER issues FAQ-format potency assessment guidance for active immunotherapy CGT products under docket FDA-2026-D-8561. Key CMC and QA implications reviewed.
FDA grants Priority Review for Teva's ecopipam NDA targeting pediatric Tourette syndrome, with a Q1 2027 PDUFA date. CMC and regulatory implications for plant heads.
Gland Pharma names Deepak Sapra CEO, shifting leadership over its sterile injectables platform. Implications for GMP compliance and global regulatory strategy.
Mankind Pharma names Sandeep Joshi as AVP International Business, reinforcing export leadership as Indian generics firms expand into regulated markets.
FDA's PDUFA VII tracker confirms CMC Development and Readiness Pilot and MAPP on CMC Challenges are complete. Key benchmarks for accelerated-development submissions.
Regeneron's Pasatru (garetosmab-grts) is FDA-approved for FOP. OPTIMA trial showed 94% HO lesion reduction. Home infusion approval raises GMP and cold-chain obligations.
FDA grants accelerated approval to Genglycos for GSDIa. QA and regulatory leads face post-approval manufacturing and confirmatory trial obligations for this AAV8 gene therapy.
B. Braun Medical recalls one lot of Excel Lactated Ringers 1000mL over cellulose and polystyrene particulate contamination. Distributed US and Canada, Aug–Sep 2024.
Ascentage Pharma reports US$44.5M in H1 2026 revenue and nine active Phase III trials, four FDA/EMA-cleared, raising GMP supply chain demands for oncology CMOs.
Telix Pharmaceuticals reports US$477M H1 2026 revenue with 65% Precision Medicine gross margin. Key regulatory dates for Pixclara, Zircaix, and Illuccix NDA reviewed.
VISUfarma secures exclusive European licensing rights for presbyopia drug YUVEZZI. Key GMP, supply chain, and regulatory implications for ophthalmic manufacturing leads.
Glenmark secures US FDA ANDA approval for generic Fluticasone Propionate Nasal Spray. Key implications for QA, manufacturing, and regulatory teams in nasal drug delivery.
Strides Pharma's Bengaluru site receives a US FDA Establishment Inspection Report, closing the inspection cycle and supporting ANDA review timelines.
FDA grants Kyverna Therapeutics RMAT designation for miv-cel in non-active secondary progressive MS, expanding an autologous CAR T platform already under BLA review.
Tilray scales medical cannabis cultivation to 275 metric tonnes across EU-GMP-certified sites in Canada and Portugal, reshaping international supply chains.
FDA grants accelerated approval to Ultragenyx's Genglycos (pariglasgene brecaparvovec-opnr), the first AAV8 gene therapy for GSD1a. CMC and post-market implications explained.
Optimal Balance Pharmacy recalls compounded glutathione 200 mg/mL multi-dose vials after elevated endotoxin detected. Adverse events reported across 14 states.
Genentech commits $750M to a flexible fill-finish device facility in Hillsboro, Oregon. Commercial operations target 2031. Key implications for GMP design and process validation.
PacBio ships SPRQ-Nx for Vega benchtop sequencer, adding 21 CFR Part 11 audit logging, 90 Gb HiFi yield, and 96-sample PureTarget multiplexing for regulated labs.
IP Australia accepts FibroBiologics' patent on cannabidiol-fibroblast cell therapy for degenerative disc disease, with implications for Asia-Pacific cell therapy development teams.
Tilray scales medical cannabis output to 275 tonnes via Quebec and EU-GMP Portugal expansions. Quebec EU-GMP certification targeted within 12 months.
Abbott settles ~2,000 NEC preterm formula claims for $670M. Learned intermediary doctrine rulings carry direct implications for QA and regulatory labeling strategy.
AuroPeptides cleared a USFDA inspection with one minor observation and initiated corrective action during the inspection. Key read for QA and regulatory leads.
Ipsen closes Kartos Therapeutics acquisition, adding Phase III MDM2 inhibitor navtemadlin for myelofibrosis. Key implications for oncology API manufacturing and GMP supply chains.
European Commission approves J&J's teclistamab plus daratumumab for second-line RRMM. Phase 3 OS data and GMP implications for combination biologics in the EU.
Cadila Pharma names Surender Narain Singh as VP of Business Development, targeting regulated export markets including the US generics sector.
Merck and Moderna's personalized mRNA cancer vaccine hits Phase 3 primary endpoint in melanoma, raising GMP scale-up, cold-chain, and CMC regulatory challenges.
Zydus Lifesciences secures USFDA approval for Ascorbic Acid Injection, reaching 448 approved ANDAs from 513 filings. Key read for QA and regulatory affairs teams.
FDA releases 55 draft product-specific guidances covering complex generics, revised bioequivalence for ferumoxytol, and new in vitro pathway for benzoyl peroxide/tretinoin.
FDA's finalized Therapeutic Equivalence guidance (FDA-2022-D-0528) resets TE code interpretation for generic manufacturers and pharmacists relying on Orange Book listings.
Empatica's FDA-cleared Parkinson's wearable monitors bradykinesia, tremor, and medication compliance continuously — with direct implications for CNS trial endpoint design.
PTC Therapeutics wins Sangamo's ST-920 AAV gene therapy for Fabry disease in a $111M bankruptcy auction. FDA accelerated approval pathway intact. Q3 2026 court hearing expected.
European Commission approves teclistamab plus daratumumab for second-line relapsed refractory myeloma. Phase 3 MajesTEC-3 data drives regulatory and supply-chain implications.
ANI Pharmaceuticals adds M&A veteran Henry Gosebruch to its board as it accelerates rare disease consolidation. Key implications for QA and regulatory leads.
Japan's MHLW approves Insmed's brensocatib for non-cystic fibrosis bronchiectasis, completing US-EU-Japan approvals. Key regulatory and pharmacovigilance implications.
FDA classifies Capricor's Deramiocel BLA amendment as major, extending the PDUFA date to November 22, 2026 after 24-month HOPE-3 data submission.
FDA's July 2026 finalized psychedelic drug guidance sets NDA and trial design requirements for MDMA sponsors. NeuroThera-Clearmind publish U.S. MDMA-PEA patent for PTSD.
Lexicon Pharmaceuticals receives its third $10M milestone from Novo Nordisk in 2026 as LX9851 Phase 1 dosing advances. Total receipts reach $75M of $1B potential.
FibroBiologics adds Leigh Steinberg to its board as the clinical-stage fibroblast therapy company advances a chronic disease and longevity pipeline with 270-plus patents.
Bristol Myers Squibb partners with Chai Discovery on AI-driven antibody discovery. Key implications for CMC timelines, QA documentation, and ICH Q10 compliance.
FDA's December 2025 counterfeit Ozempic update flags GLP-1 supply chain risks, stressing DSCSA compliance priorities for manufacturers and QA teams.
FDA's RDEA Pilot Program sets required meeting package content for rare disease novel endpoints, with incomplete submissions returned to reg affairs teams
FDA's PDUFA VII IT roadmap advances eCTD 4.0 and ESG cloud modernization. Key timelines and pilot testing plans for regulatory affairs and submission teams.
Capricor Therapeutics gains a November 2026 review date for deramiocel after a major BLA amendment, advancing its regulatory review.
Vitruvias Therapeutics recalls Thyroid Tablets USP 30 mg Lot 504950 for superpotency, highlighting QA controls for narrow therapeutic index drug release.
FDA reaffirms DSCSA obligations, import controls, and 24-hour illegitimate product notification requirements for QA directors and regulatory leads.
FDA's August 2026 DSCSA exemption for small business dispensers updates Section 582 relief. Learn waiver, exception, and exemption submissions via CDER NextGen.
FDA CDER SBIA hosts an Oct. 14 webinar on 2026 Bayesian draft guidance, covering prior distributions, estimands, and clinical trial documentation.
FDA approves Janssen’s nipocalimab-aahu (Imaavy) as the first drug for warm autoimmune hemolytic anemia, with key QA and CMO implications.
FDA places a second 2026 clinical hold on REGENXBIO’s RGX-121 after spine MRI findings in five participants, delaying its Hunter syndrome BLA resubmission.
FDA confirmed undisclosed dexamethasone in Qu Feng Huo Lou Dan pain-relief product. Key compliance signal for import surveillance and label integrity programs.
FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric and oesophageal cancers, with key labelling, companion diagnostic and QA implications.
Vitruvias Therapeutics recalls Thyroid Tablets USP 30 mg for super potency, highlighting potency controls and FDA Form 3500A reporting for solid oral dose sites.
Olympia Pharmaceuticals adds Polidocanol 2% compounded injectable to its 503B portfolio, now available across 49 states for cosmetic vein treatment in clinical settings.
Unichem Laboratories appoints Pabitra Kumar Bhattacharya as MD and CEO, marking a key leadership change for QA, regulatory and Indian generics teams to watch.
Baxter recalled 70% Dextrose Injection over stainless steel particulate, per the FDA recall notice. Scope, affected lots and what the notice states.
FDA confirms WAP Sensual Enhancement contains undeclared sildenafil, tadalafil, flibanserin, and yohimbine, raising key compliance concerns for QA and regulatory teams.
FDA's tracker flags Benznidazole and Arikayce past PMR deadlines, while Hepcludex targets completion in 2034. Review your compliance calendar now.
FDA approves Tivicay PD oral suspension for HIV in newborns from birth. IMPAACT 2023 data, PK modeling, and formulation implications for manufacturers.
Ascendis Pharma presents 104 week navepegritide data at ISDS 2026, ahead of the anticipated Q4 2026 EMA decision on YUVIWEL, a key read for regulatory leads.
Cipla's Pithampur facility received a seven-observation Form 483 after a USFDA follow-up inspection ending August 25, 2026, with key risks and CAPA priorities.
Aurigene signs a long-term manufacturing deal for 20+ drug products, covering sterile injectables, biologics and topicals, for global markets from India plants.
Baxter sodium chloride recall: fiberglass particulate found per the FDA notice. Affected products, scope and what the notice states.
FDA approves Revolution Medicines’ daraxonrasib for metastatic pancreatic cancer 6.5 months early, highlighting faster oncology regulatory pathways.
Priovant publishes Phase 3 VALOR skin outcomes for brepocitinib in JAMA Dermatology, strengthening its evidence package for dermatomyositis.
FDA approved Revolution Medicines' daraxonrasib for metastatic pancreatic adenocarcinoma using RTOR and Project Orbis, 6.5 months ahead of goal date.
AbbVie submits EMA application for risankizumab induction in Crohn's disease. Phase 3 AFFIRM data supports filing, with fill-finish and regulatory implications.
FDA accepts Nicox's NCX 470 NDA for glaucoma and sets a 30 April 2027 PDUFA date. CMC and regulatory implications for NO-donating drug hybrids explained.
Moleculin's Phase 2/3 MIRACLE trial for Annamycin in R/R AML approaches a 90-patient interim analysis, shaped by FDA input and adaptive trial design.
FDA updates Sanofi’s TENIVAC Td vaccine approval on August 26, 2026, prompting regulatory and QA teams to review revised labelling and compliance records.
Cormica TPM publishes a peer-reviewed analysis of FDA enforcement trends in 503A and 503B compounding, mapping deficiencies under 21 CFR Parts 210 and 211.
Abbott’s Amulet 360 LAA Occluder earns CE Mark for non-valvular AFib, backed by 99.8% implant success and 93.9% LAA closure at 45 days.
Verrica Pharmaceuticals completes COVE-2 Phase 3 enrollment for YCANTH in common warts, with topline data expected in Q1 2027 and FDA filing planned.
Propanc Biopharma reports over 90% inhibition of tumour growth and a 2.5-fold increase in survival with PRP in preclinical PDAC models.
Cronus Pharma gains FDA approval for generic robenacoxib injection for veterinary use, highlighting GMP and 21 CFR Part 211 requirements for sterile sites.
FDA approves Roivant's LISRAYA (brepocitinib) for dermatomyositis, first targeted TYK2/JAK1 inhibitor for the rare autoimmune disease, available now in U.S.
FDA reviewing Priovant's brepocitinib (LISRAYA) for adult dermatomyositis. Phase 3 VALOR positive; PDUFA Q3 2026. JAK inhibitor, co-dev model implications.
FDA grants supplemental approval to Sanofi Vaccines Canada's DAPTACEL DTaP vaccine. Key compliance read for biologics makers on post-approval changes.
FDA extends use dates on 14 Hospira, Baxter injectable lots — bupivacaine, dextrose, flumazenil. No relabeling required; disposal rules apply on resupply.
FDA warned compounders about adverse events linked to injectable glutathione made with supplement-grade ingredients. What the agency stated and why it matters.
Celularity's Florham Park cGMP facility will produce Dezawa MuseCells and derived products for MuseCell Innovations, with $300M projected over five years.
Teva bids up to $125M for BioXcel’s IGALMI dexmedetomidine film in a Section 363 bankruptcy sale, pending FDA approval and court clearance.
B. Braun recalls three lots of 0.9% Sodium Chloride Injection after zinc oxide particulate contamination was found in products supplied to U.S. hospitals.
CDT Equity validates AI-identified crystal structures with improved stability, solubility and manufacturability, while filing patents to extend portfolio IP.
FDA updates CDER’s withdrawn product-specific guidance list on August 28, 2026, prompting ANDA sponsors to review pipelines relying on retired guidance.
AbbVie files with the EMA for subcutaneous SKYRIZI induction dosing in Crohn’s disease, advancing IV-to-subcutaneous biologic reformulation strategies.
FDA and PDG reviewed DSCSA stabilization progress at a June 2024 joint meeting. Supply chain directors and QA leads need to act on interoperability gaps before full enforcement.
FDA's 2023 PBPK workshop advances absorption modeling for bioequivalence, biowaivers, and pediatric BA/BE assessments under ICH M13A.
FDA-PDA 33rd Joint Regulatory Conference, Sept 9–11 2024: CGMP quality systems, data integrity, aging facilities, supplier oversight for pharma ops leaders.
FDA-ISoP Nov 2023 workshop: pharmacometric modeling now central to oncology dosing in NDAs and labeling. Key read for regulatory affairs leads.
The FDA approved Takeda's Mimrylo (rusfertide), a hepcidin mimetic, for polycythemia vera. The approval's scope, the Phase 3 data behind it and the outlook.
The FDA approved Stelara (ustekinumab) for pediatric ulcerative colitis. The approval's scope, the data behind it and what it means for a biosimilar-era brand.
Maharashtra FDA cancels Cipla Pune unit drug sale licences over Reactin Plus labelling, recall, and storage failures. Key compliance implications for QA leads.
FDA approves Mounjaro to reduce MACE risk in type 2 diabetes, with implications for Lilly’s GLP-1 manufacturing capacity and supply chain planning.
FDA approves the first targeted therapy for metastatic pancreatic adenocarcinoma in pretreated adults, with key implications for manufacturing and QA.
Evonik invests C$150M in a new Vancouver facility to triple advanced pharma manufacturing capacity, strengthening CDMO supply and North American production.
TMIV Imaging launches its AI-driven CLARION CT System in India with Aegis Detector technology, targeting low-dose imaging and diagnostic quality standards.
CDMO Live Americas 2026 brings pharma and biotech leaders together in Boston for external manufacturing partnerships, CMC and drug development.
EMA launches a voluntary pilot for non-animal testing data, opening regulatory dialogue for pharma, CROs and labs through Q3 2027.
FDA issues its first draft guidance on AI model credibility for drug and biologics submissions, introducing a risk-based, context-of-use framework.
FDA warns Peptide Partners LLC for selling seven unapproved injectable peptide drugs online, including products containing semaglutide and tirzepatide.