The day in pharma, read in minutes.
NewsAgilent Launches ICP-MS, GC Systems and Digital Lab Platform
Agilent launches ICP-MS, GC systems and a digital lab platform in India as API producers face tightening elemental impurity and data integrity requirements.
Cohance Lifesciences Secures $18M Stake in NJ & Aruka Bio
RPG Life Sciences Acquires Raghava Life Sciences API Business
American Regent Recalls Three Epinephrine Lots Over Cracked Vials
Axcelead Releases FDA NAMs Road Map Seminar on IND Strategy
Latest news
11 storiesCipla InvaGen Signs Biosimilar Deal with Qilu for US Market
Cipla's InvaGen unit partners Qilu Pharmaceutical to commercialize a pembrolizumab biosimilar in the US under FDA's 351(k) pathway.
Pendopharm Secures AMC Reimbursement Nod for Yorvipath
CDA-AMC recommends conditional public reimbursement for Yorvipath in chronic hypoparathyroidism, advancing Pendopharm's Canadian market access process.
CBER Maintains Framework for Three Allergenic Products
CBER licenses three allergenic product types; potency standardization gaps in non-standardized injectable extracts remain an open regulatory question for manufacturers.
FDA Approves Zanvastro as First Treatment for Alexander Disease
FDA approves Zanvastro (zilganersen), the first treatment for Alexander disease, setting a commercial benchmark for intrathecal ASO manufacturing.
FDA Works With Six Manufacturers to Ease Estradiol Patch Shortage
FDA coordinates with six estradiol patch makers to close supply gap triggered by November 2025 boxed-warning removal, with output nearly doubled over the past year.
FDA and EMA Join Forces on Botanical Drug Development
FDA and EMA hold a joint workshop September 25, 2026, signaling regulatory harmonization for botanical drug products as sponsor activity increases.
FDA Finalizes 2026–2027 Flu Vaccine Strain Selection
FDA's VRBPAC has finalized platform-specific influenza strain selections for 2026-2027, triggering immediate batch record and QC protocol updates for vaccine manufacturers.
AbbVie Acquires Apogee Therapeutics for Half-Life Extended Antibody Pipeline
AbbVie closes $10.9B Apogee deal, triggering GMP scale-up and technology transfer for half-life extended IL-13 antibody zumilokibart.
FibroBiologics Secures U.S. Patent for 3D Spheroid Fibroblast Wound Healing Therapy
FibroBiologics patents 3D spheroid fibroblast wound therapy, raising GMP and process validation questions for cell therapy manufacturers.
AbbVie’s Etentamig Meets Dual Endpoints in Phase 3 Myeloma Trial
AbbVie's etentamig met dual primary endpoints in Phase 3 CERVINO, signaling imminent GMP and fill-finish scale-up requirements for this BCMA bispecific.
Cellipont Texas Facility Supports Six 2026 IND Programs
Cellipont Bioservices reports its Texas facility has supported six cell therapy client programs expected to reach IND submission in 2026.
Worth your time this week
Eledon Submits Islet Cell IND for Tegoprubart
WuXi AppTec Explores CDMO Shifts in Oligonucleotide Delivery
Inventiva Completes Last Patient Visit in NATiV3 Phase 3 Trial
