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Form FDA 483 Response Best Practices Announced by the FDA | JD Supra
JD Supra· 13 hours agoProcesses and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the ...
Adicet Bio gains FDA Fast Track for lupus nephritis treatment By Investing.com
Investing.com· 3 hours ago(NASDAQ: ACET), a biotechnology firm in the clinical stage, announced today that the U.S. Food and...
FDA advisers vote against first MDMA therapy to treat PTSD
CNN.com· 21 hours agoAfter hearing presentations from the US Food and Drug Administration, treatment sponsor Lykos...
Psychedelic Drug Stocks Plummet On FDA Advisers' Doubts About Ecstasy Candidate
The Wall Street Journal· 5 hours agoThe stocks fell after experts advising the FDA on Tuesday evening voted against a drug application...
FDA panel won't recommend MDMA for PTSD treatment
The Advocate & Democrat· 1 hour agoFDA advisory panel says it won't recommend the use of MDMA — more commonly known as ecstasy or molly — to treat PTSD.
FDA Panel Rejects Use of MDMA-Assisted Therapy for PTSD
Healthline via AOL· 11 hours agoAn expert panel of the Food and Drug Administration reviewed finding from two phase 3 clinical...
MDMA therapy wait goes on as FDA panel rejects Lykos’ PTSD treatment
Pharmaceutical Technology via Yahoo Finance· 10 hours agoA US Food and Drug Administration (FDA) panel has voted to decline approval of Lykos Therapeutics's...
Be Bio’s haemophilia B treatment gains FDA orphan drug status
Pharmaceutical Technology via Yahoo Finance· 10 hours agoThe US Food and Drug Administration (FDA) has granted orphan drug designation to Be Biopharma’s (Be...
Lykos' MDMA treatment rejected by FDA committee, despite being '75% of the way there'
FierceBiotech· 6 hours agoLykos Therapeutics’ attempt to get the first ever MDMA treatment approved in post-traumatic stress...
FDA Warns Recalled Cookie Dough Company Over “Serious Violations”
IFLScience· 1 day agoAfter one of its cookie dough products was taken off shelves last year following the discovery it...