Bayer’s HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer
Bayer AG (ETR: BAYN) announced that sevabertinib (trade name HYRNUO) received U.S. FDA approval for...
Product approvals
Pfizer’s Hympavzi Wins China Approval as First Weekly Non‑Factor Hemophilia Therapy
Pfizer Inc. (NYSE: PFE) announced that Hympavzi (marstacimab), the world’s first non‑factor hemophilia therapy requiring...
Regeneron’s Libtayo Wins EC Approval for Adjuvant CSCC, 68% Risk Reduction
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the European Commission (EC) approved Libtayo (cemiplimab) as adjuvant...
Acotec’s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions
Acotec Scientific Holdings Limited (HKG: 6669) announced that China’s National Medical Products Administration (NMPA) has...
Roche’s Lunsumio SC Wins EU Conditional Approval for Follicular Lymphoma
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) announced that the European Commission (EC) has granted...
PegBio’s PB‑119 (Paidakang) Wins NMPA Approval for Type 2 Diabetes Treatment
PegBio Co., Ltd. (HKG: 2565) announced that its next‑generation GLP‑1 receptor agonist PB‑119, marketed under...
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)...
Gan & Lee’s Ondibta Receives Positive CHMP Opinion – EU Biosimilar Pathway Opened
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced that the European Medicines Agency (EMA) has...
Tonghua Dongbao Secures Dominican Republic Market Launch for Insulin Aspart
Tonghua Dongbao Pharmaceuticals Co., Ltd. (SHA: 600867) announced that its Insulin Aspart Injection 3 ml : 300 IU pre‑filled...
Chongqing Precision Biotech Wins NMPA Approval for pCAR‑19B – China’s First Humanised CD19 CAR‑T Therapy for Pediatric B‑ALL
Chongqing Precision Biotech Co., Ltd. announced that its pCAR‑19B cell‑based product has received National Medical...
NMPA Grants Marketing Authorisation to Hefei Amvite’s Memantine Hydrochloride ODT for Alzheimer’s Disease
The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced...
Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products...
Grand Pharmaceutical & Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray
Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris...
Novartis Wins FDA Approval for Remibrutinib Tablets – First BTK Inhibitor for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted...
Gaush Meditech’s Subsidiary Secures China Registration for Integrated Ophthalmic Electrophysiology System
Gaush Meditech Ltd. (HKG: 2407) announced that its wholly‑owned subsidiary Gaush Tech Ltd. has been issued...
LifeTech Scientific Secures NMPA Approval for G‑Branch TAAA Stent‑Graft System
LifeTech Scientific Corporation (HKG: 1302) announced that China’s National Medical Products Administration (NMPA) has granted...
Siemens Shanghai Gains NMPA Clearance for Prostate‑Cancer AI Detection Software
Siemens Shanghai Medical Equipment Ltd. (SSME) announced that the National Medical Products Administration (NMPA) has...
UCB Wins FDA Approval for KYGEVVI in Rare Mitochondrial Disease TK2d
UCB (EBR: UCB) announced that KYGEVVI received FDA approval for the treatment of adult and...
Pluvicto Radioligand Therapy Receives Dual NMPA Approvals in China
Novartis (NYSE: NVS) has announced that its Lutetium‑177‑labelled therapy Pluvicto (lutetium ¹⁷⁷Lu‑vipivotide tetraxetan) now holds...
Zhejiang Acea Pharma Secures Conditional NMPA Approval for Olgotrelvir Sodium Capsules – First Dual‑Target COVID‑19 Oral Antiviral in China
Zhejiang Acea Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...