Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE:...
Product approvals
Life Molecular Imaging and Sinotau Pharmaceutical Secure NMPA Approval for Neuraceq in China
Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben...
MicroPort MedBot’s Toumai Robot Gains NMPA Approval for Endoscopic Surgery
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252), a leading medical robotics company, has announced...
EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu...
Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval...
Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal...
Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506)...
BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers...
AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug...
Lepu Medical Gains NMPA Approval for Semi-Automatic External Defibrillator
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced...
Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE:...
FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for...
Nanjing Geneseeq’s NSCLC TMB Detection Kit Approved by NMPA
China-based Nanjing Geneseeq Medical Device and Diagnostic Inc. has announced that its tissue tumor mutation...
Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval...
Jiangsu BioPerfectus Secures NMPA Approval for Norovirus Nucleic Acid Detection Kit
China-based Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading manufacturer of in vitro diagnostic...
Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its...
Med Vision’s Sleep Disorder Software Receives Category II Approval in China
Hangzhou-based Med Vision, a provider of virtual reality (VR)-enabled digital therapeutics (DTx) solutions, has reportedly...
Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of...
Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval...
Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received...