Amoy Diagnostics Announce NMPA Approval of China’s First KRAS G12C Companion Diagnostic
Amoy Diagnostics Co., Ltd. (“AmoyDx”) have secured approval from the China National Medical Products Administration...
Product approvals
Bayer Secures FDA Approval for Elinzanetant, First Dual NK Therapy for VMS
Bayer (ETR: BAYN) announced that the U.S. Food and Drug Administration had granted marketing approval...
Lepu Biopharma Secures Conditional NMPA Approval for Becotatug Vedotin (MGR003) in Recurrent Nasopharyngeal Carcinoma
Lepu Biopharma Co., Ltd. (HKG: 2157) today announced that its antibody‑drug conjugate (ADC) Becotatug Vedotin (MGR003)...
GSK Secures FDA Approval for Blenrep in Multiple Myeloma
GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has...
Astellas China Secures GBA Approval for First‑in‑Class Fezolinetant (VEOZA)
Astellas (TYO: 4503) China announced that its global first‑in‑class, non‑hormonal, selective neurokinin‑3 (NK3) receptor antagonist...
Huadong’s Mefatinib Approved by NMPA for EGFR‑Driven NSCLC
Huadong Medicine (SHE: 000963) announced that its Class 1 innovative drug Mefatinib Tablets has received marketing...
Hengrui Launches Henagliflozin Triple‑Combination Metformin for Type 2 Diabetes
Hengrui Medicine (SHA: 600276, HKG: 1276) today announced the commercial launch of its first independently developed...
Boehringer Ingelheim’s Nerandomilast Approved by China NMPA for Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim announced that its oral selective phosphodiesterase‑4B (PDE4B) inhibitor Nerandomilast (JASCAYD®) has received formal...
Novo Nordisk Secures FDA Approval for Rybelsus to Reduce Cardiovascular Risk in Type 2 Diabetes
Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration (FDA) has granted...
Kelun-Biotech’s Trastuzumab Botidotin Approved by NMPA for HER2-Positive Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced on October 17, 2025, that its Human...
Huadong Medicine Secures NMPA Approval for Relmapirazin Injection, Complementing MediBeacon TGFR Device
Huadong Medicine (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has granted marketing...
Sinclair’s MaiLi Precise Receives NMPA Acceptance Notice for Class III Device
Sinclair (Hangzhou) Medical Technology Co., Ltd., a wholly‑owned subsidiary of Huadong Medicine (SHE: 000963), announced...
UCB Biosciences Receives NMPA Marketing Authorization for Zilucoplan (Zilbrysq) in Adult Generalized Myasthenia Gravis
UCB S.A. (EBR: UCB), a global biopharmaceutical company, announced today that the National Medical Products...
GSK Receives China NMPA Approval for Shingrix in Immunocompromised Adults
GlaxoSmithKline (NYSE: GSK) announced today that the Chinese National Medical Products Administration (NMPA) has granted approval...
Arcutis Biotherapeutics Receives FDA Approval for ZORYVE (Roflumilast) Cream in Children 2‑5 Years with Atopic Dermatitis
Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), the U.S. partner of Huadong Medicine Co., Ltd. (SHE: 000963), announced today that...
Amoytop Biotech Secures NMPA Approval for Pegbinterferon Combination Therapy in Chronic Hepatitis B
Amoytop Biotech Co. Ltd. (SHA: 688278) announced today that the National Medical Products Administration (NMPA)...
Sichuan Kelun‑Biotech Wins NMPA Approval for Sacituzumab‑Tirumotecan in EGFR‑Mutant Lung Cancer
China‑listed Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products...
Boehringer Ingelheim Secures FDA Approval for Nerandomilast (JASCAYD) in Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim (BI) announced today that the U.S. Food and Drug Administration (FDA) has approved...
China’s NMPA Approves Mufemilast (Hemay005) — Hemei’s First Domestic PDE4 Inhibitor
The National Medical Products Administration (NMPA) announced that Jiangxi Hemei Pharmaceutical Co., Ltd. has received...
Acotec Scientific Receives FDA 510(k) Clearance for Endovenous Radiofrequency Ablation System
Acotec Scientific Holdings Limited (HKG: 6669) announced on October 7, 2025 that its Endovenous Radiofrequency Ablation System...