GE HealthCare (Nasdaq: GEHC) has received U.S. Food and Drug Administration (FDA) approval for Flyrcado™ (flurpiridaz F 18) injection, marking a significant advancement in positron emission tomography (PET) myocardial perfusion imaging (MPI) for detecting coronary artery disease (CAD). Designed for…
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.…
Bristol Myers Squibb (NYSE: BMY) has received approval from the U.S. Food and Drug Administration (FDA) for COBENFY™ (xanomeline and trospium chloride), marking a significant advancement in the treatment of schizophrenia in adults. This medication represents the first new class…
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and whose condition remains inadequately controlled. Dupixent is the first biologic…
AstraZeneca’s Tagrisso (osimertinib) has received U.S. approval for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation…
Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for treating schizophrenia in adults. This marks the first new class of schizophrenia treatment in…
Fujirebio has announced that its subsidiary, Fujirebio Diagnostics, Inc., has submitted the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test to the U.S. Food and Drug Administration (FDA) for approval. This new plasma test is poised to…
Takeda (TSE:4502/NYSE) has announced that the Japanese Ministry of Health, Labour and Welfare has approved the manufacture and marketing of FRUZAQLA Capsules (1mg/5mg), containing fruquintinib, a selective oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3.…
Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) have announced that Zenyaku has received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the intravenous injection of Rituxan® (rituximab, genetic recombination) in…
The Ministry of Health, Labour and Welfare of Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL injection for IV infusion every four weeks), Eli Lilly and Company’s (NYSE: LLY) treatment for early symptomatic Alzheimer’s disease (AD). This includes patients with…
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that it has filed for regulatory approval to launch a Phase 1/2a clinical trial for ARO-INHBE, its investigational RNA interference (RNAi) therapeutic aimed at treating obesity. The company also plans to seek regulatory…
Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven biotech company focused on developing targeted cancer therapies through its proprietary RADR® AI and machine learning platform, announced that the FDA has granted it three Rare Pediatric Disease Designations (RPDD). These designations cover…