FDA Unveils RDEP to Accelerate Rare Disease Therapy Development
The U.S. Food and Drug Administration (FDA) today issued the Rare Disease Evidence Principles (RDEP),...
Aosaikang Launches Phase III Trial of ASK202 with Leatinib for NSCLC
China’s Beijing Aosaikang Pharmaceutical Co., Ltd. (SHE: 002755) announced today that the first patient has...
Ab&B Bio‑Tech Wins NMPA Approval for First‑Ever Quadrivalent Influenza Subunit Vaccine
Ab&B Bio‑Tech CO., LTD. JS (HKG: 2627) disclosed that its quadrivalent influenza virus subunit vaccine...
Sanofi’s Tzield Earns China NMPA Approval for Stage 2 Type 1 Diabetes
French pharmaceutical giant Sanofi (NASDAQ: SNY) today announced that its investigational drug Tzield (teplizumab) has...
Zenas Secures $300 M Royalty Deal for Obexelimab – Royalty Pharma to Invest
Zenas BioPharma, Inc. (NASDAQ: ZBIO) and Royalty Pharma, Inc. (NASDAQ: RPRX) announced a milestone partnership...
Enlaza‑Vertex Partner on $45 M Multi‑Target Drug Discovery Collaboration
Enlaza Therapeutics, Inc. and Vertex Pharmaceuticals, Inc. (NASDAQ: VRTX) today announced a multi‑target drug discovery...
Servier Secures Global Rights to Darovasertib for Uveal Melanoma Treatment
French firm Servier Pharmaceutical plc. and IDEAYA Biosciences Inc. (NASDAQ: IDYA) announced an exclusive licensing...
JT118 Vaccine Receives NMPA Approval for Monkeypox Prevention
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that China’s National Medical Products...
Pfizer‑BioNTech Receives FDA Approval for New COVID‑19 Vaccine Indication for High‑Risk Adults
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) today announced that the United States...
NMPA Adds 35 New Reference‑Listed Drugs to 95th Catalog, Updates 31 Existing Specs
The National Medical Products Administration (NMPA) today announced the release of its 95th Reference‑Listed Drugs...
Hengrui Pharma Secures NMPA Approval for HRS‑7172 Targeting RAS‑Mutated Tumors
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) today announced that its novel...
MSD Reports Positive Phase 3 CORALreef Lipids Results for Oral PCSK9 Inhibitor Enlicitide
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) disclosed encouraging topline results from the...
OMass Therapeutics Teams Up with Genentech on First‑in‑Class IBD Oral Small Molecule
OMass Therapeutics, a biotechnology firm that discovers medicines targeting membrane proteins and intracellular complexes, has...
Arrowhead Partners with Novartis for ARO‑SNCA siRNA Therapy
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today unveiled a worldwide licensing and collaboration agreement with Novartis...
Novatim Licenses KY‑0301 Nano‑Bispecific ADC to RADIANCE Biopharma
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced a landmark exclusive licensing collaboration with RADIANCE Biopharma....
Zai Lab’s TIVDAK Wins Hong Kong Approval for Recurrent Cervical Cancer
China-based biotech Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) has secured a pivotal regulatory milestone:...
Fosun Launches Futuoning, First‑In‑Class CDK4/6 Inhibitor for HR‑Positive Breast Cancer
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced the nationwide launch of...
Fosun Secures FDA Approval for Two Denosumab Biosimilar Formulations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License...
Haisco Secures FDA Clinical Trial Approval for First‑In‑Class BCL6 PROTAC HSK47977
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the U.S. Food and Drug Administration...
Santen Launches Tapcom, Preservative‑Free Glaucoma Combo in China
Japan‑based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced the commercial launch of Tapcom (tafluprost/timolol maleate) in...