United States Food and Drug Administration
How do the 12 FDA-approved gene therapies break down by medical indication
The 12 FDA-approved gene therapies cover a range of medical indications, primarily focusing on genetic disorders, cancers, and hematological conditions. Here’s a breakdown of these therapies by their medical indications: Genetic Disorders: Luxturna (voretigene neparvovec-rzyl): Approved for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, which leads to vision loss and may […]
Moderna’s Diversification Strategy Hindered by FDA Delay in RSV Vaccine Review
Moderna, FDA, RSV vaccine, diversification strategy, vaccine review, delay
Moderna’s RSV Vaccine Decision Postponed by FDA to Late May
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FDA Approves Apple Watch’s Afib-Tracking App for Clinical Research
Apple Watch, afib-tracking app, FDA certification, clinical studies, heart health, medical technology, wearable devices, digital health.
Verona Pharma Prepares $650 Million Funding Pool for Ensifentrine Launch Ahead of FDA Decision
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Revolutionizing Public Health: CBER’s Peter Marks and the Vision to Reduce FDA Visits
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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.