Regulatory & Policy
FDA accepts Gilead's once-weekly oral lenacapavir as first long-acting HIV PrEP pill
The US FDA's acceptance of a supplemental New Drug Application (sNDA) for once-weekly oral lenacapavir as pre-exposure prophylaxis (PrEP) represents a...
FDA accepts Takeda's Entyvio application for pediatric ulcerative colitis and Crohn's disease
Pediatric patients with inflammatory bowel disease represent one of the most therapeutically underserved populations in gastroenterology, and Takeda's...
Innovent global first to seek approval for CLDN18.2 targeted ADC in China
China-based Innovent Biologics (HKEX: 01801) has submitted a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) for...
FDA accepts Roche's giredestrant NDA for early-stage ER-positive breast cancer adjuvant treatment
Roche (SIX: RO, ROP; OTCQX: RHHBY) has submitted a New Drug Application (NDA) to the US FDA for giredestrant, an investigational oral selective estrogen...
Replimune to resubmit BLA for oncolytic IO therapy Rp1 in melanoma after FDA alignment
Woburn, Massachusetts-based Replimune Group (Nasdaq: REPL) has announced plans to resubmit a Biologics License Application (BLA) to the US FDA for Rp1...
FDA sets November decision date for Vertex's povetacicept in IgA nephropathy
Vertex Pharmaceuticals (Nasdaq: VRTX) has received confirmation that the US FDA has accepted its Biologics License Application (BLA) for povetacicept, an...
FDA extends review of Beren Therapeutics' adrabetadex for infantile-onset Niemann-Pick disease type C
Beren Therapeutics has announced that the US FDA has extended by three months its review of the New Drug Application (NDA) for adrabetadex...
Corcept bounces back from CRL to resubmit relacorilant NDA for Cushing's syndrome
Corcept Therapeutics (Nasdaq: CORT), based in Redwood City, California, plans to resubmit its New Drug Application to the US FDA for relacorilant as a...
Outlook Therapeutics to resubmit Lytenava BLA for wAMD after FDA appeal win
Outlook Therapeutics (Nasdaq: OTLK), based in Iselin, New Jersey, plans to resubmit a Biologics License Application (BLA) to the US FDA for Lytenava...
FDA delays decision on AstraZeneca's camizestrant after ODAC reverse
AstraZeneca (LSE/STO/NYSE: AZN) has disclosed that the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the New Drug Application...
Pierre Fabre receives CHMP positive opinion for Braftovi in first-line BRAF V600E-mutant colorectal cancer
Pierre Fabre receives CHMP positive opinion for Braftovi in first-line BRAF V600E-mutant colorectal cancer
Dyne files z-rostudirsen for US approval in exon 51 DMD
Dyne Therapeutics (Nasdaq: DYN), based in Waltham, Massachusetts, has submitted a Biologics License Application (BLA) to the US FDA for zeleciment...
EU recommends AZ, Daiichi's Enhertu for HER2 tumor-agnostic indication expansion
AstraZeneca (LSE/STO/NYSE: AZN) and Daiichi Sankyo have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products...
Regeneron files Otarmeni gene therapy for EU approval in genetic hearing loss
Regeneron Pharmaceuticals (Nasdaq: REGN) has received acceptance from the European Medicines Agency for a Marketing Authorization Application for Otarmeni...
China Medical System's TYK2 inhibitor picks up China trial nod for ulcerative colitis and Crohn's disease
China Medical System Holdings [HKEX: 0867], headquartered in Hong Kong, has received clinical trial approval from China's National Medical Products...
The AllSci Brief
Systematic R&D and deal news. Daily.