United States Food and Drug Administration
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.
FDA Grants Full Approval to Pfizer’s Tivdak for Advanced Cervical Cancer Treatment
FDA, Pfizer, Tivdak, full approval, advanced cervical cancer, treatment, regulatory tracker
Federal Trade Commission Challenges Novo Nordisk’s Ozempic and Over 300 ‘Junk’ Patent Listings in FDA Database
FTC, Novo Nordisk, Ozempic, FDA, patent listings, crackdown, junk patents, pharmaceutical industry, intellectual property, drug development.
Prime Medicine Secures FDA Approval for Pioneering Gene Editing Therapy Trial
Prime Medicine, FDA approval, gene editing, clinical trial, innovative therapy, genetic diseases
FDA Approval Milestones: X4 Pharmaceuticals, Pfizer, and Genmab Secure Nods for Rare Disease and Cervical Cancer Treatments
FDA, X4 Pharmaceuticals, Pfizer, Genmab, rare disease, cervical cancer, drug approval, treatment, healthcare, biotechnology.
X4 Pharmaceuticals’ Xolremdi Granted Approval for Treating Rare Immunodeficiency Disorder
X4 Pharmaceuticals, Xolremdi, approval, rare immunodeficiency disorder, WHIM syndrome, FDA, treatment, breakthrough therapy, CXCR4 antagonist.
Pfizer’s Revolutionary Hemophilia B Gene Therapy Gains FDA Approval and Introduces Unique Warranty Program
Pfizer, FDA, Hemophilia B, Gene Therapy, Approval, Warranty, Treatment, Genetic Disorder, Blood Clotting, Healthcare, Biotechnology
FDA Approves Pfizer’s Hemophilia B Gene Therapy with a $3.5 Million Price Tag
Pfizer, FDA, hemophilia B, gene therapy, approval, pricing, healthcare, biotechnology, rare diseases, genetic disorders, treatment cost.
FDA Approves Long-Established European UTI Antibiotic by Utility Therapeutics
Utility Therapeutics, FDA, UTI antibiotic, European market, 40-plus years.