Livzon Pharmaceutical’s Lecankitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis
Livzon Pharmaceutical (HKG: 1513) announced that lecankitug, jointly developed with Beijing Kanova Biopharma, has been...
Product approvals
TYK Medicines’ Asandeutertinib Wins NMPA Conditional Approval for EGFR-Mutant NSCLC with CNS Metastases
TYK Medicines (HKG: 2410) announced that its independently developed next-generation EGFR-TKI, asandeutertinib (TY-9591), has received...
Asieris Wins EU CE Certification for APLD-2304, the World’s First Portable Single-Use Blue-Light Flexible Cystoscope
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its APLD-2304 flexible cystoscope has obtained...
Gilead’s Bixlenvo Wins FDA Approval as Smallest Once-Daily Single Tablet HIV Regimen
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
Roivant’s Lisraya Wins FDA Approval as First Targeted Therapy for Dermatomyositis
Roivant (NASDAQ: ROIV) announced that the US Food and Drug Administration (FDA) has approved Lisraya...
FDA Approves Revolution Medicines’ Rasonque (daraxonrasib), an Oral Multi‑Selective RAS(ON) Inhibitor, for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ Rasonque (daraxonrasib) for the...
NMPA Approves Novartis’ Pluvicto Plus ARPI for PSMA‑Positive mHSPC in China, Advancing Radioligand Therapy to Earlier Prostate Cancer
Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved the radioligand...
FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab
Johnson & Johnson (J&J, NYSE: JNJ) announced that the US FDA has approved the second...
FDA Approves BeOne’s Tevimbra Plus Zanidatamab and Chemotherapy for First‑Line HER2‑Positive Gastroesophageal Adenocarcinoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced that the US FDA has...
MHLW Approves Takeda’s First‑in‑Class ORZEYFUL (Oveporexton) for Narcolepsy Type 1 in Japan
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the Japanese Ministry of Health,...
EC Approves Gilead’s Trodelvy Plus Keytruda for First‑Line PD‑L1‑Positive Metastatic TNBC – 35% Reduction in Progression Risk
Gilead Sciences (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorisation for...
Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients
Ultomiris (ravulizumab injection), a long‑acting C5 complement inhibitor under AstraZeneca’s (NYSE: AZN) Rare Disease business,...
Hengrui Wins NMPA Approval for HRS‑5965 – Complement Factor B Inhibitor for Complement Inhibitor‑Naive PNH Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting
Johnson & Johnson (J&J, NYSE: JNJ) announced U.S. 510(k) regulatory clearance for MONARCH QUEST 3,...
Sino Medical Sciences Wins Turkish Approval for Ghunter Intracranial Thrombectomy Stent – Broadening Global Footprint in Ischemic Stroke Care
Sino Medical Sciences Technology Inc. (SHA: 688108) announced that its independently developed Ghunter Revascularization Device,...
Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma – First‑Ever Nod Based on MRD‑Negative Response Data
Bristol-Myers Squibb (BMS) (NYSE: BMY) announced that the US Food and Drug Administration (FDA) has...
AstraZeneca and Daiichi Sankyo’s Enhertu Wins China Approval for First-Line HER2-Positive Metastatic Breast Cancer in Combination With Pertuzumab
AstraZeneca plc (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that a new indication for...
Akeso’s Ivonescimab Wins NMPA Approval for First-Line Advanced Squamous Non-Small Cell Lung Cancer in Combination With Chemotherapy
Akeso Biopharma (HKG: 9926) announced that the National Medical Products Administration (NMPA) of China has...
NMPA Approves Geneseeq’s Fandekang NTRK Fusion Detection Kit as Companion Diagnostic for Vcare PharmaTech’s Eratrectinib
The National Medical Products Administration (NMPA) approved Geneseeq Technology Inc.‘s (a genetic cancer testing service...
Haohai Wins NMPA Approval for China’s First Domestic Trifocal Toric Intraocular Lens for Cataract Patients With Astigmatism
Shanghai Haohai Biological Technology Co. Ltd. (SHA: 688366) announced that its trifocal toric intraocular lens...