FDA launches pilot program to accelerate rare disease therapies, improving communication between sponsors and FDA staff. #RareDiseaseTherapies #FDA #ClinicalTrials
FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.
FDA authorizes updated mRNA COVID-19 vaccines targeting circulating variants for enhanced protection.
Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight...
Today, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product...
Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of...
Sunrise Growers Inc. recalls specific frozen fruit products due to possible Listeria contamination.
U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test.
FDA releases draft recommendations to modernize clinical trials, incorporating RWE, technology, and increasing diversity.
Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder...