Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food...
Product approvals
Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that it has received marketing...
Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the...
Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National...
Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from...
MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical...
NMPA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma Treatment
The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing...
Stereotaxis and MicroPort EP Receive NMPA Approval for Magbot Magnetic Navigation Ablation Catheter
US-based Stereotaxis, Inc. (NYSEAMERICAN: STXS) and its Chinese partner Shanghai MicroPort EP Medtech Co., Ltd....
Eisai’s Urece (Dotinurad) Approved by China’s NMPA for Gout Treatment with Hyperuricemia
Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the...
Lee’s Pharmaceutical Receives NMPA Approval for Generic Glaucoma Treatments
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced...
MicroPort Scientific Corp. Launches FireFalcon Balloon for Coronary Interventions with NMPA Approval
Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received...
Shenyang Hongqi Pharma Secures NMPA Approval for Pretomanid in TB Treatment
The National Medical Products Administration (NMPA) of China has officially approved pretomanid, developed by Shenyang...
AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage Small Cell Lung Cancer
UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from...
CGeneTech’s Cetagliptin Receives NMPA Approval for Type 2 Diabetes Treatment in China
The National Medical Products Administration (NMPA) in China has indicated on its website that CGeneTech...
Eisai and Biogen’s Leqembi Approved in Mexico for Early Alzheimer’s Disease Treatment
Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that their co-developed...
Merus N.V. Receives FDA Approval for Bizengri for NRG1+ Pancreatic and Lung Cancers
Holland-based Merus N.V. (NASDAQ: MRUS) has announced that it has received FDA approval for its...
Ipsen’s Bylvay Receives NMPA Clearance for Treating Itching in PFIC Patients in China
France-based Ipsen (EPA: IPN) has announced that it has received marketing clearance from the National...
Tasly Pharma Receives NMPA Approval for Generic Lioresal (Baclofen) Oral Solution
China-based Tasly Pharma Co., Ltd (SHA: 600535) has announced that it has received marketing approval...
Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval
Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical...
Luye Pharma’s Zepzelca Receives NMPA Approval for Metastatic Small Cell Lung Cancer Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from...