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...
Drug
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...
Mirror Biologics and Merck KGaA Collaborate on Phase II Trial for Colorectal Cancer Immunotherapy
US-based Mirror Biologics, Inc., an off-the-shelf immunotherapy developer, has announced a clinical trial collaboration and...
Johnson & Johnson’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease
US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Fast...
MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received...
Bayer’s Nubeqa Seeks NMPA Approval for New Prostate Cancer Indication
Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA)...