FDA
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FDA
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the food supply, cosmetics, and products that emit radiation.
FDA Approves Roche’s Evrysdi for Use in Babies Under Two Months With Spinal Muscular Atrophy (SMA)
FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder
FDA Approves NGS-Based Companion Diagnostic for EGFR Exon20 Insertion Mutant Non-Small Cell Lung Cancer Tumor Tissue
FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia
Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older
Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma
FDA Approval of Aducanumab
U.S. FDA Approves Prevnar 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older
AskBio Announces IND for LION-101 Cleared to Proceed by U.S. FDA
Pink Luminous Breast (PLB) Takes Steps Toward FDA Class III Approval
Amgen Tezepelumab BLA Submitted to U.S. FDA
Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
Pfizer and BioNTech Initiate BLA for FDA Approval of Vaccine
Viome Receives FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers
FDA Accepts Amgen’s sNDA For Otezla ®
ViiV Healthcare New Drug Application for Long-Acting Cabotegravir for Prevention of HIV
FDA Grants Accelerated Approval for GSK’s JEMPERLI (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer
U.S. FDA Approves NEXTSTELLIS ®, New Oral Contraceptive
RETINA-AI Health Awarded U.S. Patent for AI Eye Disease Detection
FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
FDA approves new treatment for adults with relapsed or refractory large-b-cell lymphoma
FDA approves first extended-release, injectable drug regimen for adults living with HIV
FDA statement on following the authorized dosing schedules for COVID-19 vaccines
