Regulatory & Policy
FDA Approves Cosentyx for Pediatric Moderate-to-Severe Hidradenitis Suppurativa in Patients Aged 12 and Older
The US FDA has approved Cosentyx (secukinumab) for the treatment of pediatric patients aged 12 years and older with moderate to severe hidradenitis...
Argo Biopharma Secures FDA Fast Track Designation for siRNA Therapy BW-20805 Targeting Hereditary Angioedema
Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage biotechnology company headquartered in Shanghai and New York, announced that the U.S....
MHRA Approves CStone's Cejemly for Unresectable Stage III NSCLC Consolidation Therapy in UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Cejemly (sugemalimab) as a monotherapy for adult patients with unresectable...
Remix Therapeutics' REM-422 Earns FDA Fast Track Designation for Adenoid Cystic Carcinoma Treatment
Remix Therapeutics, a clinical-stage biotechnology company headquartered in Watertown, Massachusetts, announced that the US FDA has granted Fast Track...
FDA accepts Cogent Biosciences' NDA for bezuclastinib in non-advanced systemic mastocytosis
Cogent Biosciences announced that the US FDA has accepted its New Drug Application for bezuclastinib in patients with non-advanced systemic mastocytosis...
FDA Issues Complete Response Letter to Disc Medicine for Bitopertin in Erythropoietic Protoporphyria Treatment
Disc Medicine, Inc. (NASDAQ: IRON) disclosed on February 13, 2026, that the U.S. Food and Drug Administration issued a Complete Response Letter for the New...
FDA approves GSK's Lynavoy for cholestatic pruritus in primary biliary cholangitis
The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis, GSK announced on...
FDA Approves Venclexta Plus Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia: AbbVie
The US FDA has approved a supplemental new drug application for the combination of Venclexta (venetoclax) and acalabrutinib for the treatment of previously...
PepGen faces FDA partial clinical hold on PGN-EDODM1 trial for myotonic dystrophy type 1
PepGen Inc. (Nasdaq: PEPG) announced that the U.S. Food and Drug Administration has placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 multiple...
China's NMPA approves Xdemvy for Demodex blepharitis, triggering $15M milestone payment to Tarsus
China's National Medical Products Administration has approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis, making...
FDA accepts Sun Pharma's Ilumya application for active psoriatic arthritis in adults
Sun Pharmaceutical Industries has submitted a supplemental Biologics License Application to the US FDA seeking approval for ILUMYA (tildrakizumab-asmn) for...
Japan approves Viatris' Effexor as first pharmacological treatment for generalized anxiety disorder
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor (venlafaxine hydrochloride) for the treatment of adults with generalized anxiety...
AnnJi Pharmaceutical's AJ201 Secures US FDA Fast Track Designation for Kennedy's Disease Treatment
FDA Grants Fast Track Designation to Promising Kennedy's Disease Treatment
FDA Approves Wellcovorin by GSK as First Treatment for Cerebral Folate Transport Deficiency
The US FDA approved Wellcovorin (leucovorin calcium) tablets on March 10, 2026, for the treatment of cerebral folate deficiency in adult and pediatric...
Affinia Therapeutics Secures FDA Fast Track Designation for BAG3 Dilated Cardiomyopathy Gene Therapy AFTX-201
Affinia Therapeutics, a clinical-stage biotechnology company headquartered in Waltham, Massachusetts, announced that the U.S. Food and Drug Administration...
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