Adagene’s Muzastotug Wins FDA Fast Track for CTLA-4 Cancer Combo
Adagene Inc. (NASDAQ: ADAG) announced that the U.S. Food and Drug Administration (FDA) granted Fast...
Drug
Aficamten Wins China Approval as HCM Drug in Global First for Sanofi
Sanofi (NASDAQ: SNY) announced that aficamten, a second‑generation cardiac myosin inhibitor, received marketing approval from...
Haisco Wins NMPA Clinical Approval for Four Category 1 Drugs, Advancing Pipeline
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed novel BTK inhibitor orelabrutinib...
ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
Sanofi’s Tolebrutinib Fails Phase 3 PPMS Endpoint, Halting Registration Plans
Sanofi (NASDAQ: SNY) announced that the Phase 3 PERSEUS study (NCT04458051) of tolebrutinib in primary progressive...
Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced first patient dosing in the Phase 2 KC1036‑COM‑01...
Johnson & Johnson’s TECVAYLI Gets FDA Priority Review for Myeloma Combo
Johnson & Johnson (NYSE: JNJ) announced that the U.S. FDA selected the teclistamab MajesTEC‑3 supplemental...
Hengrui NMPA Approves Four Clinical Trials Advancing Oncology and Metabolic Pipeline
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...
GSK’s Nucala Wins CHMP Nod for COPD in Europe
UK biopharma GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency’s Committee for...
Novo Nordisk’s Wegovy 7.2mg Gets EMA Positive Opinion for Obesity
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency’s Committee for Medicinal Products...
Innovent’s Mazdutide Wins Macau Approval for Weight Management
Innovent Biologics, Inc. (HKG: 1801) announced that mazdutide received marketing approval from Macau’s drug regulatory...
Akeso’s Cadonilimab Wins FDA Nod for Global Phase 3 Gastric Cancer Study
Akeso Biopharma (HKG: 9926) announced that the U.S. FDA approved cadonilimab in combination with chemotherapy...
Junshi Biosciences Wins FDA Nod for EGFR/HER3 Bispecific ADC in Solid Tumors
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that the U.S. Food and...
Henlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application...
Amgen’s Uplizna Scores Third FDA Indication in Myasthenia Gravis
Amgen Inc. (NASDAQ: AMGN) announced that the U.S. FDA approved Uplizna (inebilizumab-cdon) for adult patients...
Huadao Submits China CAR‑T Application for Refractory Lymphoma in $1B Market
Suzhou Huadao Biological Pharmacy Co., Ltd. officially submitted a Marketing Authorization Application (MAA) to the...
Lilly’s Retatrutide Achieves 28.7% Weight Loss in Phase 3 Obesity-Osteoarthritis Trial
Eli Lilly & Co. (NYSE: LLY) announced positive topline results from the Phase 3 TRIUMPH‑4...
Joincare’s Pixavir Marboxil Wins NMPA Approval as First Single‑Dose Flu Treatment
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that its Class 1 innovative drug, Pixavir...
InnoCare’s Zurletrectinib Wins NMPA Nod as China’s First Next-Gen TRK Inhibitor
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self‑developed next‑generation TRK inhibitor, Zurletrectinib...