Regulatory & Policy
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...
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...
FDA Approves Bristol Myers Squibb's Sotyktu for Active Psoriatic Arthritis in Adults
The US FDA has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, Bristol Myers Squibb announced on 6 March...
MetaVia secures global patent portfolio for DA-1726 dual agonist obesity therapy through 2041
MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company headquartered in the US, announced on February 13, 2026, that it has assembled a...
AnaCardio and Helsinn secure US patent for AC01 calcium sensitizing heart failure treatment
AnaCardio AB (Sweden), a clinical-stage biopharmaceutical company developing contractile agents for heart failure, and its partner Helsinn Healthcare SA...
FDA Grants Sanofi's Venglustat Breakthrough Therapy Designation for Type 3 Gaucher Disease Treatment
Sanofi (EURONEXT: SAN; NASDAQ: SNY), a Paris-headquartered biopharma company, announced that the US FDA has granted Breakthrough Therapy designation to...
Acurx Pharmaceuticals Secures US Patent for Innovative DNA Polymerase IIIC Inhibitor Technology
USPTO Grants Acurx Pharmaceuticals Patent for Innovative DNA Polymerase IIIC Inhibitor Technology
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