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NewsBristol Myers Squibb Signs AI Deal With Chai To Accelerate Drug Discovery
BMS partners with Chai Discovery to apply AI to antibody discovery, compressing timelines with implications for CMC and regulatory documentation.
FibroBiologics Appoints Leigh Steinberg as Board Director to Advance Longevity Pipeline
Lexicon Secures Third $10M Milestone from Novo Nordisk for Phase 1 Dosing
SciSparc-Clearmind Collaboration Wins U.S. MDMA-PEA Patent
FDA Extends PDUFA Review for Capricor’s Deramiocel
Latest news
11 storiesInsmed Gains MHLW Approval In Non-Cystic Fibrosis Bronchiectasis Across Three Major Markets
Insmed's MHLW approval of brensocatib for NCFB completes a US-EU-Japan regulatory arc, marking the first approved treatment in the indication across all three major markets.
ANI Pharmaceuticals Appoints Henry Gosebruch to Board as Rare Disease Pivot Accelerates
ANI Pharmaceuticals adds M&A veteran Henry Gosebruch to its board as the company accelerates its rare disease consolidation strategy.
Johnson & Johnson Wins EU Approval for Teclistamab-Daratumumab Combo
EU approves teclistamab plus daratumumab for second-line RRMM, based on Phase 3 MajesTEC-3 survival data.
PTC Acquires Sangamo’s Fabry Gene Therapy for $111M
PTC Therapeutics wins Sangamo's BLA-stage AAV Fabry gene therapy ST-920 for $111M in a Delaware bankruptcy auction, with accelerated approval pathway intact.
Empatica Gains FDA Clearance for Continuous Parkinson's Disease Monitoring Platform
Empatica's FDA-cleared Parkinson's monitoring platform raises the bar for objective endpoint design in CNS clinical trials.
FDA Finalizes Therapeutic Equivalence Guidance Changing Orange Book TE Codes
FDA finalizes TE code guidance under docket FDA-2022-D-0528, clarifying Orange Book evaluations for generic manufacturers and pharmacists.
FDA Issues 55 New Guidances to Speed Up Generic Drugs Development
FDA releases 55 draft PSGs covering complex generics, with revised bioequivalence guidance for ferumoxytol and benzoyl peroxide/tretinoin.
Zydus Gains FDA Approval for Ascorbic Acid Injection, Lifting ANDA Portfolio to 448
Zydus Lifesciences reaches 448 ANDA approvals after FDA clears Ascorbic Acid Injection, with 513 total filings as of June 2026.
Merck and Moderna Achieve Phase 3 Primary Endpoint with mRNA Cancer Vaccine in Melanoma
Merck and Moderna's mRNA cancer vaccine hits Phase 3 primary endpoint, raising immediate GMP and cold-chain scale-up questions for personalized biologics.
Cadila Pharma Appoints Surender Narain Singh as VP of Business Development
Cadila Pharma appoints Surender Narain Singh as VP of Business Development, signalling a push into regulated export markets.
Johnson & Johnson Wins EU Approval for Teclistamab Combo in Myeloma
EC approves J&J's teclistamab plus daratumumab for second-line RRMM, backed by Phase 3 OS data, raising supply and GMP implications for combination biologics.
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Ipsen Acquires Kartos Therapeutics, Adding Navtemadlin to Oncology Pipeline
AuroPeptides Clears FDA Inspection With Just One Observation
Abbott Settles 2,000 NEC Claims for $670M, Shifts Legal Strategy
