Eisai and Biogen Win EU Approval for Leqembi in Early Alzheimer’s Disease
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that they have...
Product approvals
Edwards Lifesciences Gains EU CE Mark for SAPIEN M3 Mitral Valve System
US medical device giant Edwards Lifesciences Corporation (NYSE: EW) has announced that it has received...
Roche’s Columvi Approved by EC for Relapsed DLBCL Treatment in Europe
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing...
MSD’s Gardasil 9 Approved in China for Males Aged 16 to 26
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced marketing approval from...
Bristol-Myers Squibb Wins FDA Approval for Opdivo-Yervoy Combo in First-Line HCC Treatment
Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval from the US Food and...
Belief BioMed and Takeda Win NMPA Approval for China’s First Hemophilia B Gene Therapy
China-based gene therapy specialist Belief BioMed Inc. and Takeda’s (NYSE: TAK, TYO: 4502) China unit...
KingstronBio’s Prostyle A Valve Gains NMPA Approval, Setting New Benchmark in Transcatheter Aortic Valve Replacement
KingstronBio, a Changshu-based structural heart disease device manufacturer, has obtained marketing approval from China’s National...
Jemincare Group Announces NMPA Approval of Generic Clenil for Asthma Treatment
China-based Jiangxi Jemincare Group has announced that it has received marketing approval from the National...
Bayer’s Vitrakvi Fully Approved by FDA for NTRK Fusion Solid Tumors
Germany-based Bayer (ETR: BAYN) announced that it has received full approval from the US Food...
Luye Pharma Launches Rotigotine Luye in UK for Parkinson’s and Restless Leg Syndrome
China-based Luye Pharma Group (HKG: 2186) announced the market launch of Rotigotine Luye in the...
Hansoh Pharma’s Ibrexafungerp Approved for Vulvovaginal Candidiasis in China
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced this week that it has received...
Hengrui Pharmaceuticals’ Ivarmacitinib Approved for Atopic Dermatitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received additional indication approval...
B. Braun’s DUPLEX System Approved by FDA for Piperacillin and Tazobactam
B. Braun Medical Inc., a US-based healthcare company, announced that the U.S. Food and Drug...
Peijia Medical’s YonFlow Stent Approved by China’s NMPA
Peijia Medical Ltd (HKG: 9996) announced that it has received market approval from China’s National...
Gaush Meditech’s Corneal Confocal Microscope Approved in Jiangsu
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced that it has received market approval from the...
AbbVie’s Rinvoq Approved in EU for Giant Cell Arteritis
US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval in the...
Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved for MSI-H Colorectal Cancer
Bristol-Myers Squibb (BMS, NYSE: BMY) announced this week that the US Food and Drug Administration...
Yifan Pharma Secures NMPA Approval for Generic Sedapain
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that it has received marketing approval...
Daiichi Sankyo and AstraZeneca’s Datroway Approved in EU for Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (NASDAQ: AZN) announced that their co-developed...
Hengrui Pharmaceuticals’ Vunakizumab Approved for Ankylosing Spondylitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received additional indication approval...