Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to ...
FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move ...
The FDA said it would start releasing rejection letters soon after they are provided to drugmakers, a victory for transparency advocates.
Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, which founded Lykos, bemoaned a ...
Stealth’s injection, known as elamipretide, will be sold as Forzinity for the treatment of Barth syndrome, an X-linked ...
Capricor Therapeutics has publicly released its July response to the FDA's rejection of its Duchenne muscular dystrophy cell therapy deramiocel after the agency included deramiocel in a new batch of ...
The FDA said Sept. 4 it will release complete response letters, or product rejection letters, “promptly after they are issued” to manufacturers. The agency also published 89 previously unreleased ...
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