Healthcare ❯ Regulatory Affairs

FDA

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Clear Eyes Recalls Nearly 40,000 Bottles Over Sterility Concerns

Class II designation by the FDA signals potential reversible harm, prompting scrutiny of manufacturing and retail practices.

FDA Advisory Panel Recommends Six Peptides for Pharmacy Compounding

FDA Advisory Panel Narrowly Backs Compounding of Six Unapproved Peptides

Fulcrum Halts Pociredir Development After FDA Flags PRC2 Cancer Risk

Ironwood Sets 2026 Targets After LINZESS Price Cut as Shares Surge

FDA Expands Review of Possible COVID Vaccine-Linked Deaths to Multiple Age Groups

FDA Weighs Ending Pfizer COVID-19 Authorization for Children Under 5

FDA Lifts Pause on Valneva’s Chikungunya Vaccine for Seniors

FDA Shifts COVID-19 Vaccine Policy to Focus on High-Risk Groups