Regulatory & Policy
FDA approves Denali Therapeutics' Avlayah for neurologic symptoms of Hunter syndrome in pediatric patients
The US FDA has granted accelerated approval to AVLAYAH (tividenofusp alfa-eknm), an enzyme replacement therapy developed by Denali Therapeutics for the...
FDA Grants ENHERTU Priority Review for HER2-Positive Early Breast Cancer Post-Neoadjuvant Treatment
Daiichi Sankyo Co., Ltd. (TSE: 4568), headquartered in Tokyo, and AstraZeneca (LSE/STO/NYSE: AZN), headquartered in Cambridge, UK, announced that the U.S....
Drug Farm's DF-003 Secured US FDA Orphan Drug Designation for ROSAH Syndrome
Drug Farm, a private biotechnology company with operations in Albany, New York, and Shanghai, announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Tecvayli Plus Darzalex Faspro for Relapsed or Refractory Multiple Myeloma
The US FDA has approved Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of adults...
FDA Approves ACCRUFeR by Shield Therapeutics as First Prescription Oral Iron for Pediatric Iron Deficiency
The US FDA has approved ACCRUFeR (ferric maltol) for the treatment of iron deficiency in children aged 10 years and older, Shield Therapeutics announced on...
Oncolytics Biotech's Pelareorep Secures US FDA Fast Track Designation for KRAS-Mutant Colorectal Cancer
Oncolytics Biotech Secures FDA Fast Track for Pelareorep in Hard-to-Treat Colorectal Cancer
Polaryx Therapeutics Secures FDA Fast Track Designation for PLX-200 Targeting Rare CLN2 Disease
Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company headquartered in Paramus, New Jersey, announced that the U.S. Food and...
FDA approves Rhythm Pharmaceuticals' Imcivree for acquired hypothalamic obesity in adults and children
The US FDA has approved an expanded indication for IMCIVREE (setmelanotide), developed by Rhythm Pharmaceuticals, to treat acquired hypothalamic obesity in...
Lunai Bioworks receives US patent for AI-driven data debiasing methods in drug discovery predictions
Lunai Bioworks, Inc. (NASDAQ: LNAI), an AI-driven biotechnology company headquartered in Sacramento, California, announced on 19 February 2026 that the US...
FDA approves Bristol Myers Squibb's Opdivo for previously untreated advanced classical Hodgkin lymphoma
On March 20, 2026, the US FDA approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric...
China's NMPA grants priority review to Gyre Therapeutics' Hydronidone for CHB-induced liver fibrosis
Gyre Therapeutics has announced that China's National Medical Products Administration (NMPA), through its Center for Drug Evaluation (CDE), has granted...
FDA Approves GSK's Arexvy for At-Risk Adults Aged 18–49 Against RSV Disease
The US FDA has approved an expanded age indication for Arexvy (respiratory syncytial virus vaccine, adjuvanted), GSK's recombinant protein-based RSV...
Sciwind Biosciences' Ecnoglutide Approved in China for Chronic Weight Management in Adults
China's NMPA Approves Ecnoglutide, the First cAMP-Biased GLP-1 Receptor Agonist for Chronic Weight Management
AstraZeneca's Imfinzi Approved in EU for Early-Stage and Locally Advanced Gastric Cancer
The European Commission has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy as the first perioperative immunotherapy for adults with...
FDA approves Novo Nordisk's Awiqli, the first once-weekly basal insulin for type 2 diabetes
The US FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, developed by Novo Nordisk, as an adjunct to diet and exercise to improve...
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