FDA Removes Key RWE Limitation, Allowing Drug and Device Submissions Without Individual Patient Data
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accept Real-World...
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...
uBriGene Partners with Circurna on circRNA Manufacturing for Global Trials
uBriGene Biosciences International Co. announced a strategic partnership with Circurna, a biotechnology company developing next‑generation...
Dren Bio, Sanofi Forge $1.8B B‑Cell Therapy Deal with US Co‑Promote Option
Dren Bio, Inc. announced a strategic collaboration with Sanofi (NASDAQ: SNY) to discover and develop...
Adaptive Licenses TCR Data to Pfizer in $890M Deal for Rheumatoid Arthritis
Adaptive Biotechnologies Corporation (NASDAQ: ADPT) announced two non‑exclusive agreements with Pfizer Inc. (NYSE: PFE) to...
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...
Sobi Acquires Arthrosi for $1.5 Billion to Add Gout Drug to Portfolio
Swedish Orphan Biovitrum AB (Sobi) (STO: SOBI) announced a definitive agreement to acquire Arthrosi Therapeutics,...
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...
Cellular Origins Raises $40M Series A Led by Johnson & Johnson for Cell Therapy Manufacturing
Cellular Origins announced the completion of an over‑subscribed $40 million Series A financing round led by...
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...
China Healthcare Fund Settlement Reform Targets 3% Ratio by 2028
The National Healthcare Security Administration (NHSA) released a notice to optimize healthcare fund settlement management,...
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...
Hanx Biopharma Prices HKEX IPO to Fund Bispecific Antibody Pipeline
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. released its prospectus for a Hong Kong Stock Exchange listing...
China Unveils Elderly Nursing Plan to Boost 90% Nurse Coverage by 2027
China’s National Health Commission (NHC), National Healthcare Security Administration (NHSA), National Administration of Traditional Chinese...