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Clinical lab industry sues to block FDA’s new oversight of lab-developed tests
FierceBiotech· 3 hours agoThe U.S. trade group representing laboratory companies and test manufacturers is suing to block the ...
FDA staff outline shortcomings of Lykos data for MDMA therapy
BioPharma Dive via Yahoo Finance· 6 hours agoAhead of an advisory panel meeting, agency staff identified several sticking points in the clinical...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
WFMJ Youngstown· 2 hours agoThe experts will discuss the quality of the evidence and safety concerns Tuesday, including MDMA's...
US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
AOL· 3 hours agoModerna's vaccine was approved by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. RSV, which produces symptoms similar ...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
Dayton Daily News· 3 hours agoWASHINGTON (AP) — Federal health regulators are questioning the safety and evidence behind the first...
US FDA approves Moderna's RSV vaccine, its second marketed product
Reuters· 2 hours ago, opens new tab respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks· 13 hours agoFree Report) and Regeneron (REGN Quick QuoteREGN - Free Report) announced that the FDA extended the review period for a regulatory filing seeking label expansion for their ...
FDA updates recall of lead-tainted cinnamon
Consumer Affairs· 3 days agoA recall of tainted cinnamon seasoning for lead contamination is still in effect, with the U.S. Food and Drug Administration (FDA) updating its warning...
Guest column: With FDA approval of software treatment for depression, the digital medicine...
WRAL TechWire· 7 hours agoIn a watershed moment for digital health innovation, the FDA recently granted clearance to Rejoyn, a...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
WPXI· 3 hours agoThe experts will discuss the quality of the evidence and safety concerns Tuesday, including MDMA's...