Sanofi’s SAR446523 Gains FDA Orphan Drug Status for Relapsed or Refractory Multiple Myeloma
French pharmaceutical major Sanofi (NASDAQ: SNY) reported that the U.S. Food and Drug Administration (FDA)...
Product approvals
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...
Bayer’s Sevabertinib Granted Priority Review by China’s NMPA for NSCLC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced on July 28, 2025, that the marketing...
Pierre Fabre’s Braftovi Approved in China for BRAF V600E-mutant Metastatic Colorectal Cancer
France-based Pierre Fabre Laboratories announced that Braftovi (encorafenib) in combination with cetuximab has been approved...
Henlius Biotech’s HLX14 Recommended for EU Approval by EMA’s CHMP
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Type 2 Diabetes Treatment with Insulin
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced that the National Medical Products Administration...
Antengene’s XPOVIO Approved for New Multiple Myeloma Indication by China’s NMPA
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that the China National Medical Products Administration...
BeOne Medicines’ Tislelizumab Receives Positive CHMP Opinion for NSCLC Treatment
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its PD-1 antibody...
Bristol-Myers Squibb Gains NMPA Approval for Opdivo-Yervoy Combo in NSCLC
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that it has received another indication approval...
Aidea Pharma’s Aitribond Approved by Zanzibar Food and Drug Agency
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that its anti-HIV-1 drug Aitribond has...
Sobi North America’s Doptelet Approved by FDA for Pediatric ITP Treatment
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today...
Sansure Biotech’s Gene Polymorphism Detection Kits Receive NMPA Class III IVD Certification
China-based Sansure Biotech Inc. (SHA: 688289) announced on July 28, 2025, that it has received...
Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
France-based Sanofi (NASDAQ: SNY) announced that the European Commission has approved its anti-CD38 monoclonal antibody...
Yangtze River Pharmaceutical’s Tadalafil Hydrochloride Tablets Approved for ED Treatment in China
China-based Yangtze River Pharmaceutical Group announced on July 25, 2025, that its Class 1 innovative...
Ipsen’s Cabometyx Approved by European Commission for Neuroendocrine Tumors
France-based pharmaceutical company Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced that its anticancer drug Cabometyx...
Shanghai Kehua Bioengineering Subsidiary Receives Two IVD Certificates from NMPA
China-based Shanghai Kehua Bioengineering Co., Ltd. (KHB) (SHE: 002022) announced on July 23, 2025, that...
Shanghai MicroPort EP MedTech’s IceMagic Catheter Receives EU MDR Certification
Shanghai-based Shanghai MicroPort EP MedTech Co., Ltd. (SHA: 688351) announced on July 23, 2025, that...
Wondfo Biotech’s MSI Detection Kit Granted NMPA Marketing Clearance
Guangzhou-based Wondfo Biotech (SHE: 300482) announced that the National Medical Products Administration (NMPA) has granted...
Zhongke Yian Receives NMPA Approval for Innovative Sirolimus-Eluting Coronary Stent
ZhongKe Yian Medical Technology (Beijing) Co., Ltd. has secured approval from China’s National Medical Products...
NMPA Approves World’s First Plant-Based Human Albumin for Liver Cirrhosis Treatment
China’s National Medical Products Administration (NMPA) has approved the world’s first plant-based human albumin, a...