United States Food and Drug Administration – Page 14

Neurogene Details New Safety Measures After Young Patient’s Death in Rett Syndrome AAV Gene Therapy Trial

3 months ago talkbio0Tagged AAVS1 gene, ASGCT, Clinical Trials, Dosage, gene therapy, Individual Adjustment, Lymphohistiocytosis, Hemophagocytic, Measures, MECP2 gene, Neurogene, NGN-401, Rett Syndrome, Safety, United States Food and Drug Administration

Neurogene; AAV gene therapy; Rett syndrome; NGN-401; ASGCT; safety measures; HLH; clinical trial; MECP2 gene; FDA; dose adjustment

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

3 months ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

Mayne Pharma Faces FDA Action Over ‘Misleading’ Drug Safety Claims Ahead of $430M Buyout

3 months ago talkbio0Tagged Claims, Contraceptives, Oral, Cosette Pharmaceuticals, drug safety, Mayne, Nextstellis, Pharma, United States Food and Drug Administration

Mayne Pharma; FDA; misleading claims; Nextstellis; birth control pill; drug safety; buyout; Cosette Pharmaceuticals

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

3 months ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

3 months ago talkbio0Tagged AbbVie, Accelerated, ADC, Approved, Emrelis, Malignant neoplasm of lung, MET protein, human, Non-Small Cell Lung Carcinoma, Protein Overexpression, Solid Neoplasm, Telisotuzumab, therapeutic autologous dendritic cells, United States Food and Drug Administration, vedotin-tllv

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

Merck’s Keytruda Achieves Industry-First Success in Preventing Head and Neck Cancer Recurrence: AACR 2025 Highlights

3 months ago talkbio0Tagged AACR, Cancer of Neck, Clinical Trials, Event-Free Survival, Head, KEYNOTE-689 trial, Keytruda, locally advanced head, Merck, pembrolizumab, perioperative, recurrence prevention, Squamous cell carcinoma, United States Food and Drug Administration

Keytruda; Merck; AACR 2025; head and neck cancer; resectable locally advanced head and neck squamous cell carcinoma; event-free survival; KEYNOTE-689 trial; perioperative pembrolizumab; recurrence prevention; clinical trial; FDA

FDA, CDC call for pause of chikungunya shot rollout in older adults

4 months ago talkbio0Tagged Adverse event, Centers for Disease Control and Prevention (U.S.), Chikungunya Fever, concerns, Elderly (population group), Ixchiq vaccine, pause recommendation, Safety, United States Food and Drug Administration

Ixchiq vaccine, chikungunya, safety concerns, older adults, FDA, CDC, pause recommendation, adverse events

Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis

4 months ago talkbio0Tagged Approved, DTC Campaign, Empowerment, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, self-administration, Syringes, United States Food and Drug Administration, Vyvgart Hytrulo

Vyvgart Hytrulo, prefilled syringe, FDA approval, self-administration, generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), DTC campaign, patient empowerment