United States Food and Drug Administration – Page 15

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

FDA Delays Continue as Regulator Misses Review Date for GSKs Nucala

4 months ago talkbio0Tagged Chronic Obstructive Airway Disease, delays, GSK 's, Nucala, PDUFA, Target, United States Food and Drug Administration

United States Food and Drug Administration, Nucala, Chronic Obstructive Airway Disease, GSK ‘s, Target, delays, PDUFA

Vinay Prasads FDA Appointment Anything but Status Quo

4 months ago talkbio0Tagged Anything, Appointments, Prasad, Prasad 's, Status Quo, United States Food and Drug Administration, Vaccines

United States Food and Drug Administration, Appointments, Vaccines, Prasad, Prasad ‘s, Anything, Status Quo

FDA eyes full AI integration by June as Makary touts genAI pilot success

4 months ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, DNA Integration, June, Makary, United States Food and Drug Administration

United States Food and Drug Administration, Aortic Valve Insufficiency, DNA Integration, Artificial Intelligence, Makary, June

In first oncology expert meeting under Makary, FDA spotlights cancer drugs from J&J, Pfizer, Roche and UroGen

4 months ago talkbio0Tagged J&J, oncology expert, Pfizer, Roche (company), United States Food and Drug Administration, UroGen

United States Food and Drug Administration, oncology expert, J&J, Pfizer, Roche (company), UroGen

FDA Vaccine Advisory Committee to Determine 2025-2026 COVID-19 Vaccine Formulation

4 months ago talkbio0Tagged Advisory Committees, COVID19 (disease), Formula - diet, meeting, strain selection, United States Food and Drug Administration, Vaccines, VRBPAC

COVID-19 vaccines, FDA advisory committee, strain selection, 2025-2026 formula, vaccine updates, VRBPAC meeting

Compounders just lost their case to put obesity drug tirzepatide back in shortage

4 months ago talkbio0Tagged Drug Shortage, Eli, Eli Lilly, Facilities Association, Glucagon-Like Peptide 1, Legal Case, Mounjaro, OFA, tirzepatide, United States Food and Drug Administration, Zepbound

Tirzepatide, compounding, FDA, drug shortage, Eli Lilly, Zepbound, Mounjaro, legal case, Outsourcing Facilities Association (OFA), GLP-1 medications

Biotech stocks plunge and industry figures left to wonder after Prasad’s FDA appointment

4 months ago talkbio0Tagged Appointments, Cell Therapy, figures, Industry, Market, Prasad, stocks, United States Food and Drug Administration

United States Food and Drug Administration, Industry, Prasad, Appointments, stocks, Cell Therapy, Market, figures

Trumps US Manufacturing Push, New Vaccine Policy, Novos Weight Loss Pill up for FDA Review

4 months ago talkbio0Tagged Policy, trade deficits, United States Food and Drug Administration, Vaccines

Policy, trade deficits, Vaccines, United States Food and Drug Administration