Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...
Product approvals
Henlius Organon Secure EU Marketing Approval for BILDYOS and BILPREVDA Denosumab Biosimilars
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission...
Innovent Secures 2nd NMPA Approval for Mazdutide – First Dual GLP‑1/GCGR Therapy for Type 2 Diabetes
Innovent Biologics Ltd. (HKG: 1801) announced that its mazdutide injection (IBI362) has received its second...
Novo Nordisk Rybelsus Gains Cardio Benefit from SOUL Trial
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products...
Sino Biopharmaceutical Secures NMPA Approval for Degarelix Generic in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Haisco Pharma Secures NMPA Approval for Anrikefon in Hemodialysis‑Related Pruritus
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the China National Medical Products Administration...
Fovinaciclib CDK4/6 Breaks Ground in Breast‑Cancer Therapy
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its subsidiary Avanc...
Shenzhen Kangtai Receives NMPA Approval for Sabin‑Strain Inactivated Polio Vaccine
Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) announced today that the China National Medical...
Novartis Secures Tabrecta Approval in China for METex14 NSCLC
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its MET‑receptor tyrosine kinase inhibitor Tabrecta (capmatinib...
Johnson & Johnson Secures FDA Approval for INLEXZO, a Ground‑breaking Intravesical System for Bladder Cancer
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug...
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...
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:...