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.

Today, the vast majority of new food additives, most of them industrially produced, make it to market via the GRAS pathway through a loophole. The post How some food additives bypass the FDA review

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage at the same time under a new coverage pathway announced Thursday by the FDA and the Centers for Medicare & Medicaid Services (CMS).

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,

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,

By Padmanabhan Ananthan April 23 (Reuters) - AbbVie said on Thursday the U.S. Food and Drug Administration has declined to approve its experimental wrinkle treatment, trenibotE, citing issues in manufacturing.