Bio-Sincerity Pharma-tech Gains NMPA Approval for BIOS-0618 in Obstructive Sleep Apnea
Hangzhou Bio-Sincerity Pharma-tech Corp., Ltd (SHE: 301096) has secured clinical trial approval from China’s National...
Drug
Santen’s Tapcom Approved by China’s NMPA for Glaucoma Treatment
Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from China’s National...
Enhertu Approved by EC for Earlier-Line Treatment of HR+/HER2-low Breast Cancer
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval...
Sino Biopharmaceutical’s TQB2101 Receives NMPA Approval for Phase I Trial in Advanced Malignancies
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the National...
Hengrui Pharmaceuticals Gains NMPA Approval for HRS-6719 in Solid Tumors
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clinical trial...
Sanofi’s Rilzabrutinib Granted Orphan Drug Designation for Rare Diseases
Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received Orphan Drug Designation (ODD) from...
Sunshine Guojian’s SSGJ-627 Gains NMPA Approval for Ulcerative Colitis Trial
China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG:...
Sarepta and Roche Seek to Resume Elevidys Trials After EMA Halt
The European Medicines Agency (EMA) may lift the temporary hold on certain Phase III studies...
Bayer’s Vividion Therapeutics Starts Phase I Study for RAS-PI3Kα Inhibitor
German pharmaceutical giant Bayer’s (ETR: BAYN) wholly owned subsidiary Vividion Therapeutics, Inc. has announced the...
Fujian Kerui’s Generic Sirolimus Gel Approved by China’s NMPA
China-based Fujian Kerui Pharmaceutical Co., Ltd. announced that its generic version of Pfizer’s (NYSE: PFE)...
Henlius Biotech’s HLX04-O Shows Positive Results in wAMD Phase III Trial
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced positive results from the Phase III...
Mabwell Bioscience’s 7MW3711 ADC Receives Clinical Trial Approval in China
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that it has received clinical trial...
Novartis’ Vanrafia Gets FDA Accelerated Approval for IgAN
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food...
Shionogi Partners with Link Medical for Cefiderocol Development in Australia and New Zealand
Japan-based Shionogi Co., Ltd. has entered into an exclusive licensing agreement with Link Medical Products...
Guojian Qingke Biomedical Gains NMPA Approval for 3D MSCs in Stroke Trials
China-based Guojian Qingke Biomedical Technology (Beijing) Co., Ltd. announced that it has received tacit clinical...
Gan & Lee Pharmaceuticals Secures Pakistan Approval for Insulin Glargine Cartridge
Gan & Lee Pharmaceuticals (SHA: 603087) has announced the receipt of marketing approval for its...
Biogen’s BIIB080 Receives FDA Fast Track Designation for Alzheimer’s
US-based Biogen Inc. (NASDAQ: BIIB) announced that it has received Fast Track designation (FTD) from...
Novartis’ Fabhalta Approved in China for C3 Glomerulopathy
Novartis’ (NYSE: NVS) Fabhalta (iptacopan) has received approval from China’s National Medical Products Administration (NMPA)...
Shionogi Submits Rolling NDA for Ensitrelvir in US for COVID-19 Prophylaxis
Shionogi announced on April 1, 2025, the initiation of a rolling New Drug Application (NDA)...
Pfizer Expands Abrysvo RSV Vaccine Indication to Include Ages 18-59 in EU
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has amended the marketing...