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FDA

Drug Approval Process Vaccine Approval Process Clinical Trials Youth Protection Drug Development Vaccine Approval Drug Review Process Tobacco Control Public Health Vaccine Eligibility Drug Approval

5 ARTICLES

last mo.

FDA Grants Accelerated Approval for RP1 (Tudriqev) With Nivolumab in Advanced Melanoma

The agency based its decision on response‑rate results from a single‑arm IGNYTE trial with continued approval contingent on an ongoing randomized confirmatory study.

6 ARTICLES

last mo.

FDA Authorizes Four Flavored Nicotine Pouches as Health Groups Raise Alarms

7 ARTICLES

7mo ago

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

40 ARTICLES

7mo ago

FDA Refuses to File Moderna’s mRNA Flu Vaccine Application Over Trial Comparator

6 ARTICLES

11mo ago

FDA Backs Leucovorin for Cerebral Folate Deficiency as White House Promotes Autism Use