Browsing Tag
Marty Makary
3 posts
HIMS near 52-week low as FDA issues 30 GLP-1 warning letters
FDA sends 30 warning letters to GLP-1 compounders, targeting Hims & Hers Health (HIMS) as regulatory and legal pressure intensifies. Read what it means for investors and the sector.
Vanda Pharmaceuticals (VNDA) wins FDA’s first formal drug approval hearing in 40 years as Hetlioz jet lag battle enters new phase
FDA grants Vanda Pharmaceuticals a rare Part 12 public hearing on Hetlioz jet lag rejection, the first such drug approval hearing in 40 years. Read the full analysis.
Vinay Prasad returns to top FDA post amid political whiplash and gene therapy fallout
Dr. Vinay Prasad has been reinstated as Chief Medical and Scientific Officer at the U.S. FDA just weeks after stepping down. His reappointment is reshaping biotech regulatory dynamics and reviving questions about scientific independence under political pressure.