Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)
Otsuka; anti-APRIL antibody; Voyxact; sibeprenlimab; FDA approval; IgA nephropathy; IgAN; proteinuria; monoclonal antibody
FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months
FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval
Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny
Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold
BridgeBio Oncology Therapeutics: Recent News Overview (November 2025)
BridgeBio Oncology Therapeutics; Helix Acquisition Corp II; de-SPAC transaction; PIPE financing; RAS and PI3Kα; clinical-stage biopharma; AACR-NCI-EORTC Conference; third quarter 2025 financial results
FDA OKs Sarepta Study of New Immune Suppression Approach with Elevidys; Gilead Acquires Preclinical TREX1 Program
FDA; Sarepta; Elevidys; immunosuppression; Duchenne muscular dystrophy; Gilead; TREX1; gene therapy; sirolimus; acute liver injury
CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks
CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date
Zentek Appoints Mohammed Jiwan as CEO
Zentek; Mohammed Jiwan; CEO appointment; ZenGUARD; nanomaterials; graphene; technology; commercialization
Curapath and Cristal Therapeutics Sign Co-Exclusive License of CliCr Bioconjugation Platform
Curapath; Cristal Therapeutics; CliCr Bioconjugation Platform; co-exclusive license; nucleic acid delivery; CDMO; drug delivery
Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade
Dupixent; chronic spontaneous urticaria (CSU); EU approval; Sanofi; Regeneron; monoclonal antibody; IL-4; IL-13; CUPID phase 3 trials; type 2 inflammation
Novo Nordisk’s Amycretin Significantly Reduces Weight and Blood Sugar in Phase 2 Type 2 Diabetes Trial
Novo Nordisk; Amycretin; Type 2 diabetes; Weight loss; HbA1c reduction; GLP-1 agonist; Amylin receptor agonist; Phase 2 clinical trial; Subcutaneous administration; Oral administration