Topic
FDA
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FDA
5 pieces on this counter
· 5 min
Six Peptides Win Compounding Access as HHS Overrides FDA Staff
HHS Secretary Robert F. Kennedy Jr. cleared compounding of six restricted peptides against FDA staff advice. Pharmacies must meet strict sourcing, testing and…
· 3 min
FDA Finalizes Rules for Mandatory Cosmetics Recalls
The FDA finalized guidance on October 23 explaining when it will force mandatory recalls of unsafe cosmetics — its first such power, granted under MoCRA in 202…
· 2 min
Cosmo's Clascoterone Posts Strong 12-Month Hair Loss Data
Clascoterone 5% solution delivered 2.39-fold greater hair count improvement at 12 months. Cosmo will file for FDA approval in early 2027, the first new mechani…
· 2 min
FDA Clears Phase 2a Trial of Dual-Target Antibody NAV-240 for HS
Navigator Medicines has begun dosing patients in an FDA-cleared phase 2a trial of NAV-240, a dual-target antibody blocking TNF and O40L in moderate to severe H…
· 2 min
FDA Reviews Zoryve Cream for Eczema in Babies as Young as 3 Months
The FDA accepted Arcutis' application for Zoryve (roflumilast) cream in infants 3 months and up with eczema. A decision is expected in early 2027, with nearly…
