Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the...
Product approvals
Pfizer’s Adcetris Gets New FDA Approval for Lymphoma Treatment
US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from...
Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration...
Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for...
Lifetech Scientific’s Aortic Stent Graft System Wins NMPA Approval
China-based Lifetech Scientific Corporation (HKG: 1302) announced that it has received market approval from the...
MicroPort MedBot’s Toumai Surgical Robot Wins NMPA Approval for Single-Hole Laparoscopy
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that the National Medical Products Administration...
J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s...
China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval...
CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the...
Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National...
NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520)...
Nuance Pharma’s Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment
China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre...
Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval...
Keymed Biosciences’ Kangyueda Gains NMPA Approval for Seasonal Allergic Rhinitis
China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from...
AbbVie’s Emblaveo Wins FDA Approval for Complicated Intra-Abdominal Infections
US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the...
Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd...
Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US...
FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody...
Sino Medical Sciences’ NC Rockstar Catheter Gains MDA Approval in Malaysia
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval...
Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug...