Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration...
Product approvals
Australian Scleral Lens Epicon A Approved by China’s NMPA as 10th Novel Product
Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the...
WinHealth Pharma Receives NMPA Approval for Glycerol Phenylbutyrate for Urea Cycle Disorders
China-based Hong Kong WinHealth Pharma Group Ltd has announced receiving market approval from the National...
NMPA Approves Suzhou MicroPort Joint Medical Technology’s Zirconium Niobium Alloy Femoral Head for Hip Replacement
The National Medical Products Administration (NMPA) has granted marketing approval to Suzhou MicroPort Joint Medical...
Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from...
China Medical System’s Diazepam Nasal Spray Receives NMPA Approval for Cluster Seizures
China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application...
AstraZeneca’s Soliris Secures Third Indication for Myasthenia Gravis in China
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class...
Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the...
NMPA Approves Shanghai Magic Medicine’s Innovative Multimodal Tumor Treatment System
The National Medical Products Administration (NMPA) has granted marketing approval to Shanghai Magic Medicine’s multimodal...
NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus
The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE:...
NMPA Approves Shenzhen Core Medical’s Implantable Left Ventricular Assist System
The National Medical Products Administration (NMPA) has issued market approval for the implantable left ventricular...
NMPA Clears Medtronic’s Corindus for Marketing of Advanced Coronary Surgery Systems
The National Medical Products Administration (NMPA) has granted marketing approval for the “coronary artery interventional...
NMPA Grants Market Approval for Lanzhou Kejin Taiji’s Carbon Ion Therapy System
The National Medical Products Administration (NMPA) in China has issued market approval to Lanzhou Kejin...
CStone Pharmaceuticals and Blueprint Medicines’ Ayvakit Wins FDA Approval for ISM Treatment
Partners CStone Pharmaceuticals (HKG: 2616) and Blueprint Medicines have announced that the US FDA has...
CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from...
Betta Pharmaceuticals’ Befotertinib Approved by China’s NMPA for EGFR-Mutated NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National...
CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment
China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National...
BeiGene’s Brukinsa Receives Canadian Approval for Chronic Lymphocytic Leukemia
China-based BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that its Bruton’s tyrosine...
Chia Tai Tianqing’s Biosimilar Rituximab Approved by China’s NMPA for Lymphoma Treatments
China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products...
MabPharm’s CMAB007 Receives NMPA Approval for IgE-Mediated Asthma Treatment
Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has...