Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration...
Drug
Pfizer’s Sasanlimab Shows Positive Results in Phase III CREST Study
US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III...
NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR...
Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the...
GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe...
Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval...
Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for...
Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD)...
Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA...
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted...
Bayer’s Elinzanetant Meets All Primary Endpoints in Phase III OASIS 4 Study
Germany-based Bayer AG (ETR: BAYN) has announced that the Phase III OASIS 4 study for...
Inmagene Biopharmaceuticals Posts Positive Results for IMG-007 in Atopic Dermatitis
Inmagene Biopharmaceuticals, a Sino-US biotech that recently merged with US-based Ikena Oncology, Inc. (NASDAQ: IKNA),...
GSK Launches Cabotegravir Injection in China for HIV Pre-Exposure Prophylaxis
UK-based GlaxoSmithKline (GSK; NYSE: GSK) has announced the official commercial launch of its cabotegravir injection...
NHSA Revises 2024 NRDL Drug Information Based on Public Feedback
China’s National Healthcare Security Administration (NHSA) has announced revisions to the information about certain drugs...
Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products...
HuidaGene Therapeutics Receives EMA Orphan Designation for HG004 Gene Therapy
Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced a positive opinion from the European Medicines...
Mabwell’s 9MW2821 Granted Breakthrough Therapy Designation by CDE for Urothelial Carcinoma
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug...
Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing...
Fujian Cosunter’s COVID-19 Therapy GST-HG171/ritonavir Approved in Macau
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that its Category 1 product,...
Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from...