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)...
Product approvals
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...
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...
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...