Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai,...
Product approvals
Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products...
Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from...
Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received...
Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the...
Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar...
GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the...
LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission...
SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical...
Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has...
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...
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...