Fosun Secures FDA Approval for Two Denosumab Biosimilar Formulations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License...
Product approvals
Santen Launches Tapcom, Preservative‑Free Glaucoma Combo in China
Japan‑based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced the commercial launch of Tapcom (tafluprost/timolol maleate) in...
Hansoh Pharma Secures Second FDA‑Approved Indication for Inebilizumab in IgG4‑Related Disease
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its inebilizumab injection has received...
Mabwell Secures First Overseas Approval for Denosumab Biosimilars in Pakistan
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the Drug Regulatory Authority of Pakistan...
Eisai & Biogen Secure FDA Approval for Lecanemab Auto‑Injector – Home‑Based Alzheimer’s Therapy
Japan-based Eisai (TYO: 4523) and US-based Biogen (NASDAQ: BIIB) announced that the U.S. Food and...
Boehringer Ingelheim & Sino Biopharma Secure Conditional Approval for Zongertinib in China
In a joint announcement, Boehringer Ingelheim (BI) and Sino Biopharmaceutical Limited (HKG: 1177) confirmed that the...
Santen Receives Boao Lecheng Approval for RYJUSEA – A Preservative‑Free Atropine Eye Drop for Pediatric Myopia
Japan‑based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced that its RYJUSEA (atropine sulfate hydrate) has...
Gilead’s Yeytuo Gains EU Marketing Authorization for Twice‑Yearly HIV‑1 PrEP
European Commission Grant – On 26 Aug 2025 Gilead Sciences (NASDAQ: GILD) announced that the European Commission...
Humanwell Secures NMPA Approval for Remimazolam ICU Sedation
China‑based Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration...
Anke Biotech Secures Long‑Acting FSH‑CTP Approval in China
Shanghai Bao Pharmaceuticals Co., Ltd. has received official marketing authorization from China’s National Medical Products Administration (NMPA)...
Wusheng Erlunbao: Sinopharm’s First‑of‑Its‑Kind Hexavalent Rotavirus Vaccine Receives NMPA Approval
The Wuhan Institute of Biological Products Co., Ltd., a subsidiary of Sinopharm Group Co., Ltd....
Lepu Medical Secures NMPA Approval for Innovative Sodium Hyaluronate Dermal Filler
China-based Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) announced today that its self‑developed Class III...
Zhongsheng Pharma’s Onradivir Granted Drug Registration in Macau
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced that its onradivir tablets have received a...
Novartis’ Atrasentan Approved in China for IgAN Proteinuria Reduction
Switzerland-based Novartis (NYSE: NVS) has received approval from China’s National Medical Products Administration (NMPA) for...
MicroPort CardioFlow’s Alwide Plus Wins EU CE Mark for Heart Valve Procedures
China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), based in China, announced that its independently...
Acotec Scientific’s Micro-Guidewire Receives Beijing Medical Products Administration Approval
China-based Acotec Scientific Holdings Limited (HKG: 6669) announced that its micro-guidewire has received registration approval...
Novo Nordisk’s Wegovy Granted FDA Approval for Metabolic-Associated Steatohepatitis
Danish biopharmaceutical giant Novo Nordisk A/S (NYSE: NVO) announced on August 15, 2025, that its...
FDA Accelerates Approval of Dordaviprone for H3 K27M-Mutant Diffuse Midline Glioma
The U.S. Food and Drug Administration (FDA) granted accelerated approval on August 6, 2025, to...
FDA Approves Precigen’s Papzimeos for Recurrent Respiratory Papillomatosis”
The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), developed by Precigen,...
Novartis’ Leqvio Approved by FDA as Standalone Therapy for Hypercholesterolemia
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced on August 12, 2025, that the U.S. Food...