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NewsFibroBiologics Secures Australian Patent Acceptance for Cannabidiol-Fibroblast Combination in Disc Degeneration
IP Australia accepts FibroBiologics' patent on cannabidiol-fibroblast combination therapy for degenerative disc disease, extending its IP estate into Asia-Pacific.
Genentech Invests $750M in Hillsboro Fill-Finish Facility to Expand U.S. Device Manufacturing
PacBio Launches SPRQ-Nx Chemistry on Vega Benchtop System with 21 CFR Part 11 Audit Logging
Optimal Balance Pharmacy Recalls Compounded Glutathione Vials After Elevated Endotoxin Levels Detected
Ultragenyx Gains FDA Accelerated Approval for Genglycos in GSD1a, First-Ever Gene Therapy for the Disease
Latest news
11 storiesTilray Expands Annual Cannabis Cultivation Capacity Across EU-GMP-Certified Sites
Tilray scales cultivation to 275 MT across EU-GMP-certified sites in Canada and Portugal, reshaping international medical cannabis supply chains.
Kyverna Therapeutics Gains RMAT Designation for Miv-Cel in Progressive Multiple Sclerosis
FDA grants Kyverna's miv-cel RMAT designation for naSPMS, adding a third indication to an autologous CAR T manufacturing platform already under BLA review.
Strides Pharma Gains FDA Report for Bengaluru Manufacturing Facility
Strides Pharma's Bengaluru site receives FDA EIR, closing the inspection cycle with no outstanding compliance actions.
Glenmark Gains US FDA Approval For Generic Fluticasone Nasal Spray
Glenmark secures US FDA approval for generic Fluticasone Propionate Nasal Spray, expanding its ANDA portfolio in a technically demanding dosage form category.
VISUfarma Signs European Licensing Deal For YUVEZZI
VISUfarma secures exclusive European licensing rights for presbyopia drug YUVEZZI, advancing Lupin's specialty ophthalmology strategy in regulated EU markets.
Ascentage Pharma Runs Nine Phase III Trials Amid 29% H1 Growth
Ascentage Pharma reports 29% H1 2026 revenue growth while running nine global Phase III trials, four cleared by FDA and EMA.
Telix Reports 22% Revenue Growth as Radiopharma Portfolio Scales
Telix reports US$477M in H1 2026 revenue, up 22%, as Illuccix and Gozellix scale and multiple regulatory reviews advance simultaneously.
B. Braun Recalls Lactated Ringers 1000mL Over Contamination
B. Braun recalls one lot of Excel Lactated Ringers 1000mL over cellulose and polystyrene particulate contamination distributed across the US and Canada.
Ultragenyx Wins FDA Approval for Genglycos in GSDIa Patients
FDA grants accelerated approval to Genglycos for GSDIa, the first gene therapy for the condition, with confirmatory trial obligations ahead.
Regeneron Wins FDA Approval for Pasatru in FOP, Enables Home Infusion
Regeneron's Pasatru gains FDA approval for FOP, with home infusion support raising GMP, cold-chain, and packaging compliance questions for ultra-rare biologics.
FDA Completes PDUFA VII CMC Deliverables, Sets Submission Benchmarks
FDA's PDUFA VII tracker flags two completed CMC deliverables that set submission benchmarks for accelerated-development products.
Worth your time this week
Mankind Pharma Appoints Sandeep Joshi as Associate Vice President of International Business
Gland Pharma Appoints Deepak Sapra as CEO Amid Global Injectable Expansion
Teva Gains FDA Priority Review for Ecopipam NDA Targeting Pediatric Tourette Syndrome
