Regulatory & Policy
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
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...
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...
FDA Approves Loargys by Immedica Pharma for Hyperargininemia in Arginase 1 Deficiency Patients
The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in adult and pediatric patients aged two...
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
Aprea Therapeutics secures Australian and Japanese patents for WEE1 and ATR inhibitor cancer programs
Aprea Therapeutics, Inc. (Nasdaq: APRE), a clinical-stage biopharmaceutical company headquartered in the US, announced the expansion of its global...
FDA Grants Hemab Therapeutics Breakthrough Therapy Designation for Sutacimig in Glanzmann Thrombasthenia
Hemab Therapeutics, a late-stage clinical biotechnology company headquartered in Cambridge, Massachusetts, and Copenhagen, Denmark, announced that the U.S....
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...
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...
NMPA Approves IND for HBM7575/SKB575 by Harbour BioMed and Kelun-Biotech in Atopic Dermatitis
China's NMPA Clears IND for HBM7575/SKB575, a Bispecific Antibody Targeting TSLP in Atopic Dermatitis
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...
Diamyd Medical Secures Crucial US Patent for Intralymphatic Type 1 Diabetes Immunotherapy Approach
Diamyd Medical Secures Key US Patent Protection for Intralymphatic Type 1 Diabetes Immunotherapy Approach
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...
FDA Aligns on Accelerated Approval Pathway for NovaBridge's Givastomig in Gastroesophageal Cancer
Clarification: This article concerns a regulatory pathway alignment, not a formal drug approval. The US FDA has not approved givastomig. The source material...
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...
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