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Form FDA 483 Response Best Practices Announced by the FDA | JD Supra
JD Supra· 14 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 ...
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...
FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology via Yahoo Finance· 3 days agoModerna has secured approval from the US Food and Drug Administration (FDA) for its mRNA-based respiratory syncytial virus (RSV) vaccine mRESVIA...
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 Says No to MDMA as Treatment for PTSD
KLAX-TV· 8 hours agoMelissa Decker Barone, a psychologist with the Department of Veterans Affairs, said during the meeting, the AP reported. The FDA is expected to make a...
Will there be a new Covid vaccine in the fall?
NBC Universal via AOL· 45 minutes agoBruce Gellin, the chief of global public health strategy at the Rockefeller Foundation, in a discussion following the vote. Dr. Peter Marks, the FDA's...
FDA Panel Says No to MDMA as Treatment for PTSD | FOX 28 Spokane
FOX 28 Spokane· 8 hours agoMelissa Decker Barone, a psychologist with the Department of Veterans Affairs, said during 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 panel won't recommend MDMA for PTSD treatment
The Advocate & Democrat· 2 hours 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 first MDMA treatment amid deep concerns about flawed trials
NBC News via Yahoo News· 20 hours agoA Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA,...
