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Denali's (DNLI) Candidate Selected for FDA's START Pilot Program
Zacks· 15 hours agoFree Report) announced that the FDA has selected experimental candidate DNL126 in support of clinical trials advancing the rare disease therapeutics (START) Pilot Program.
FDA panel to review psychedelic drug MDMA for first time By Reuters
Investing.com· 9 hours agoThe meeting by the agency's independent experts is the farthest that a drug based on MDMA, commonly...
FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex
Pharmaceutical Technology via Yahoo Finance· 9 hours agoCalifornia-based biotech Quince Therapeutics has won fast track designation from the US Food and...
FDA advisers consider MDMA therapy to treat PTSD - WSVN 7News | Miami News, Weather, Sports | Fort...
7 News Miami· 7 hours agoIt’s the first time the FDA’s advisers have considered a psychedelic drug for medical use. The novel...
FDA Platform Technology Designation Program aims to speed development of drugs, biological products...
JD Supra· 13 hours agoFDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act ( ...
Could ecstasy or molly be used to treat PTSD? FDA panel is set to decide
NBC Washington· 2 hours agoThe FDA panel will vote later Tuesday on whether to recommend the drug's use for PTSD, which could...
FDA panel to review psychedelic drug MDMA for first time
Reuters· 9 hours agoThe meeting by the agency's independent experts is the farthest that a drug based on MDMA, commonly...
Psychedelic drug MDMA faces FDA panel in bid to become first-of-a-kind PTSD medication
Medical Xpress· 2 hours agoFederal health advisers are weighing the first-of-a-kind approval of MDMA, the mind-altering club...
BAI, FDA in tieup to accelerate vaccine testing - BusinessWorld Online
BusinessWorld· 7 hours agoTHE Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA) signed a memorandum...
MDMA meets the advisory committee
Politico· 4 hours agoWith Erin Schumaker and Megan R. Wilson FDA ADVISERS WEIGH MDMA TREATMENT — The FDA is convening an advisory committee today tasked with weighing whether ...