Approved
FDA Grants Approval for First Interchangeable Biosimilars to Regeneron’s Eylea
FDA, biosimilars, interchangeable, Regeneron, Eylea, approval, blockbuster, drug, treatment, eye diseases, macular degeneration, diabetic retinopathy, retinal vein occlusion
EU Upholds Approval of PTC Therapeutics’ Duchenne Muscular Dystrophy Treatment
EU, PTC Therapeutics, Duchenne Muscular Dystrophy (DMD), treatment, approval, rejection, committee.
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
WHO Approval for Takeda’s Dengue Vaccine: A Breakthrough in Global Health
WHO, Takeda, dengue vaccine, prequalification, global health, regulatory tracker, breakthrough, approval.
Amgen’s Breakthrough Lung Cancer Drug Approved by FDA for Lethal and Challenging Subtype
Amgen, FDA, lung cancer, breakthrough drug, SCLC, small cell lung cancer, treatment, approval
Bristol Myers’ Breyanzi Expands Indications to Include Follicular Lymphoma
Bristol Myers, Breyanzi, CAR-T therapy, follicular lymphoma, FDA approval, cancer treatment, immunotherapy.
Novo Nordisk’s Wegovy Shines as a Promising Obesity Treatment: A 4-Year Analysis
Novo Nordisk, Wegovy, obesity treatment, weight loss, 4-year data, clinical trials, blockbuster drug, GLP-1 receptor agonist, FDA approval, semaglutide.
FDA to Review Lilly’s Alzheimer’s Drug Donanemab in June Advisory Committee Meeting
FDA, Lilly, Alzheimer’s, donanemab, June, AdCom, review, approval, treatment, neurodegenerative disease.
Controversy Surrounds FDA’s Fast-Track Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
FDA, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), gene therapy, accelerated approval, controversy, clinical trials, efficacy, safety, patient advocacy, regulatory process.
Ingrezza, a Neurocrine Biosciences Drug, Receives FDA Approval for Tardive Dyskinesia Treatment
Neurocrine Biosciences, Ingrezza, FDA approval, tardive dyskinesia, neuropsychiatric disorder, valbenazine, first-of-its-kind treatment.