MicusRx’s Contezolid Sodium NDA Accepted for Review by NMPA
China-based Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373) announced that a New Drug Application (NDA)...
Market approval filings
Kelun-Biotech’s Sacituzumab Tirumotecan Accepted for NMPA Review for HR+, HER2- Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that another indication approval filing for its...
Zhaoke Ophthalmology’s Cyclosporine Eye Gel NDA Accepted by NMPA
China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that the New Drug Application (NDA) for its...
Boehringer Ingelheim’s Nerandomilast Filing Accepted for Review in Progressive Pulmonary Fibrosis
Boehringer Ingelheim announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products...
Zelgen Biopharmaceuticals Submits New Indication Application for Jacktinib in Severe Alopecia Areata
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has submitted a new...
Betta Pharmaceuticals Secures Macau Approval for Ensartinib
China-based Betta Pharmaceuticals (SHE: 300558) announced a market approval filing in Macau for its ensartinib,...
BeiGene’s Sonrotoclax Gains NMPA Priority Review for MCL Treatment
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a China-based oncology specialist proposing to change...
Hengrui Pharma Files for New Dalpiciclib Indication in Early Breast Cancer
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that a new indication approval filing...
Novo Nordisk’s Once-Daily Wegovy NDA Accepted for FDA Review
Denmark-based Novo Nordisk (NYSE: NVO) announced that its New Drug Application (NDA) filing for its...
BeiGene’s Sonrotoclax NDA Accepted by NMPA for CLL/SLL Treatment
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a China-based oncology specialist proposing to change...
AbbVie Files BLA for TrenibotE in Moderate to Severe Glabellar Lines Treatment
US-based AbbVie (NYSE: ABBV) announced that it has filed a Biologics License Application (BLA) with...
Medtronic Submits 510(k) Applications for Interoperable Diabetes Management System
US-Irish firm Medtronic plc (NYSE: MDT) has submitted twin 510(k) applications to the U.S. Food...
Zai Lab’s Augtyro NDA Accepted by China’s NMPA for NTRK Fusion Solid Tumors
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug...
Viatris Submits Marketing Application for Effexor SR in Japan for Generalized Anxiety Disorder
Viatris Inc. (NASDAQ: VTRS) announced the submission of a marketing application to Japan’s Ministry of...
Biogen’s High-Dose Spinraza Regimen Accepted for CDE Review in China
US-based Biogen Inc. (NASDAQ: BIIB) announced that the Center for Drug Evaluation (CDE) in China...
InnoCare Pharma’s Zurletrectinib NDA Accepted by China’s CDE for TRK Fusion Cancers
Beijing-based biopharmaceutical company InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that China’s Center for...
Peijia Medical’s TaurusTrio TAV System Accepted for NMPA Review in China
China-based Peijia Medical Ltd (HKG: 9996) has announced that the National Medical Products Administration (NMPA)...
Bayer Submits Eylea 8 mg for RVO Macular Edema Approval in EU
German pharmaceutical giant Bayer (ETR: BAYN) announced that it has submitted an indication approval filing...
AIM Vaccine’s Serum-Free Rabies Vaccine Accepted for Review by NMPA
China-based AIM Vaccine Co., Ltd (HKG: 6660) announced that its market filing for a serum-free...
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...