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FDA Approval Process

Priority Review Drug Studies Clinical Trials Advisory Committees Biologics License Application Vaccine Applications Drug Approval for HIV Prevention

Moderna Cuts 2025 Revenue Forecast by $1 Billion, Shares Drop Over 20%

The biotech firm cites declining COVID-19 vaccine demand, slow RSV vaccine adoption, and increased competition as key challenges.

FDA Approves First Treatment for Niemann-Pick Disease Type C

Lenacapavir Injection Shows 96% Efficacy in Preventing HIV

FDA Approves Neffy, the First Needle-Free Epinephrine Nasal Spray for Anaphylaxis