GSK Gains FDA Clearance for Benlysta Autoinjector in Pediatric Lupus Nephritis
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food...
Drug
Medilink Therapeutics’ YL201 Wins FDA Breakthrough Therapy Designation for SCLC
Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
TransThera Sciences’ Tinengotinib Gains FDA Fast Track for mCRPC Treatment
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced...
XtalPi Signs LOI With DoveTree for AI-Powered Drug Development
Shenzhen-based QuantumPharm Inc., known as Xtalpi Inc. (HKG: 2228), announced the signing of a Letter...
Merck’s Prevymis Approved in China for Pediatric CMV Prevention
US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that its novel non-nucleoside...
Sansure Biotech Wins NMPA Approval for Fungal Infection Detection Kit
China’s National Medical Products Administration (NMPA) has approved Sansure Biotech Inc.’s (SHA: 688289) Pneumocystis jirovecii,...
Vcanbio Submits Clinical Trial Application for VUM02 in Severe Pneumonia Treatment
China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) announced that its clinical trial...
Simcere Halts R&D on Alzheimer’s Drug Candidates Amid Pipeline Setbacks
Simcere Pharmaceutical Group (HKG: 2096) has reportedly discontinued research and development of its Alzheimer’s disease...
Yifan Pharma Wins NMPA Approval for Norditropin Biosimilar Trial
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that it has received clinical trial approval...
GSK’s Linerixibat Accepted for EMA Review for Cholestatic Pruritus in PBC
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the...
Sanofi’s Sarclisa Recommended for EU Approval in Newly Diagnosed Multiple Myeloma
France major Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Novo Nordisk’s Ozempic Gets Positive CHMP Opinion for Peripheral Artery Disease
Denmark-based Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency’s (EMA) Committee for...
Hengrui Pharmaceuticals Wins NMPA Approval for Six Novel Solid Tumor Drugs
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approvals from the...
Gan & Lee Pharmaceuticals Presents Phase II Results of GZR18 and GZR4 at ADA Scientific Sessions
China-based Gan & Lee Pharmaceuticals (SHA: 603087) presented multiple Phase II clinical outcomes for its...
EMA Panel Recommends Bio-Thera’s Usymro for Autoimmune Diseases
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Eli Lilly’s Efsitora Meets Key Endpoints in Phase III Trials for Type 2 Diabetes
US major Eli Lilly and Company (NYSE: LLY) presented detailed results from the Phase III...
Johnson & Johnson’s Imbruvica Secures CHMP Recommendation for Expanded MCL Use
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products...
Bayer’s Nubeqa Receives Positive CHMP Opinion for mHSPC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced last week that the European Medicines Agency...