United States Food and Drug Administration
Verona Pharma Prepares $650 Million Funding Pool for Ensifentrine Launch Ahead of FDA Decision
Verona Pharma, COPD, Ensifentrine, FDA, funding pool, launch, clinical trials, chronic obstructive pulmonary disease
Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
CBER, Peter Marks, FDA, public health, healthcare innovation, regulatory affairs, biologics, vaccines, medical devices, preventive measures.
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.
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.
FDA Panel to Evaluate Lykos’ Innovative Psychedelic Treatment for Post-Traumatic Stress Disorder
FDA, Lykos, psychedelic therapy, PTSD, mental health, clinical trials, review panel, innovative treatment, mental health breakthrough.
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