Novartis Expands Iptacopan Approval to IgA Nephropathy in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its first‑in‑class oral inhibitor Iptacopan (Fabhalta) has...
Product approvals
DaAn Gene Secures NMPA Approval for First HIVDNA Diagnostic Kit
China‑based DaAn Gene Co., Ltd. (SHE: 002030), a research arm of Sun Yat‑sen University, announced that...
Grand Pharma Secures CE Mark for SIR‑Spheres Y‑90, Expanding Liver‑Cancer Treatment Portfolio
Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR‑Spheres Y‑90 resin microsphere injection (brand name:...
InnoCare Pharma Secures Singapore HSA Approval for Orelabrutinib in Relapsed MZL
Shanghai‑based InnoCare Pharma (HKG: 9969, SHA: 688428) announced on September 8, 2025 that its Bruton’s tyrosine kinase...
Takeda Secures FDA Approval for VONVENDI’s Expanded Use in Adult and Pediatric VWD
Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) today confirmed that the U.S. Food and Drug...
Innovent’s Xinbimin IGF‑1R Antibody Approved in Macau
China-based Innovent Biologics Inc. (HKG: 1801) announced that the Macau Special Administrative Region drug authority...
Ab&B Bio‑Tech Wins NMPA Approval for First‑Ever Quadrivalent Influenza Subunit Vaccine
Ab&B Bio‑Tech CO., LTD. JS (HKG: 2627) disclosed that its quadrivalent influenza virus subunit vaccine...
Sanofi’s Tzield Earns China NMPA Approval for Stage 2 Type 1 Diabetes
French pharmaceutical giant Sanofi (NASDAQ: SNY) today announced that its investigational drug Tzield (teplizumab) has...
Pfizer‑BioNTech Receives FDA Approval for New COVID‑19 Vaccine Indication for High‑Risk Adults
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) today announced that the United States...
Zai Lab’s TIVDAK Wins Hong Kong Approval for Recurrent Cervical Cancer
China-based biotech Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) has secured a pivotal regulatory milestone:...
Fosun Secures FDA Approval for Two Denosumab Biosimilar Formulations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License...
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)...