After an executive order, the FDA announced it would prioritize the study of some psychedelic drugs for therapeutic use. Which did they choose and why?

While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.

The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But its pathway to passage is likely to face hurdles.

The FDA’s new practice of releasing redacted complete response letters (CRLs) in the name of “radical transparency” is ruffling some feathers in the drug industry, as illustrated through a new peti | The citizen petition takes issue with the FDA's new practice of publicly releasing batches of complete response letters in response to unapproved drug applications.

The FDA issued a complete response letter regarding AbbVie’s biologics license application for trenibotulinumtoxinE, a fast-acting botulinum toxin, requesting more information about its manufacturing processes,

In the most recent Untitled Letter, regulators said language around “fast and lasting responses,” organ-level benefits and symptom improvement overstated what clinical data supports for the cGVHD therapy.

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360,