Regulatory & Policy
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...
Henlius Bio readies first-in-class EGFR/c-MET bispecific ADC for Phase I in China
Shanghai Henlius Biotech (HKEX: 2696) announced on May 21, 2026 that China's National Medical Products Administration has approved the investigational new...
Henlius advances STEAP1/CD3/ CD28 trispecific T-cell engager to Phase I in prostate cancer
Shanghai Henlius Biotech (HKEX: 2696) has received clearance to initiate a Phase I clinical trial of HLX3902, a trispecific T-cell engager antibody...
Shanghai Henlius puts B7H3 bifunctional fusion protein into Phase I testing for advanced solid tumours
Shanghai Henlius Biotech (HKEX: 2696) dosed the first patient in the HLX316 clinical trial, a Phase I first-in-human study evaluating the B7-H3-targeting...
CHMP backs tumor-agnostic EU use of Enhertu across HER2-positive solid tumors
Daiichi Sankyo and AstraZeneca's Enhertu receives CHMP recommendation for HER2-positive solid tumors in the EU
IntraBio aiming Aqneursa as first ever treatment for ataxia-telangiectasia
IntraBio files for AQNEURSA approval in ataxia-telangiectasia, seeking first-ever treatment for the rare neurological disease
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