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FDA issues 510(k) clearance for Getinge’s Talis +ACG software
Medical Device Network via Yahoo Finance· 1 day agoIn April 2024, Getinge obtained a European Union Medical Device Regulation certificate for its...
Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab
Zacks via Yahoo Finance· 2 days agoIf Eli Lilly's (LLY) donanemab is approved by the FDA, it will become the second drug approved by...
FDA took months to react to complaint about Abbott infant formula factory, audit finds
Atlanta Journal-Constitution· 16 hours agoThe U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint...
Leo’s single-dose autoinjector secures FDA approval for atopic dermatitis
Pharmaceutical Technology via Yahoo Finance· 20 hours agoAccording to GlobalData’s analysts, atopic dermatitis presents a mine of opportunities, particularly...
Supreme Court preserves access to abortion drug: How will it affect Mississippi?
The Clarion Ledger via Yahoo News· 2 hours agoChristopher Green, a University of Mississippi School of Law professor, said changes are more likely...
The Ignored Aesthetic Standing Argument In FDA v. Alliance for Hippocratic Medicine
Reason.com· 9 hours agoIn FDA v. Alliance for Hippocratic Medicine, the Court rejected three theories of standing: (1) expected conscience objections, (2) expected monetary harms, and (3) diversion ...
FDA grants IND clearance for Allay’s trial of post-surgical pain treatment
Clinical Trials Arena via Yahoo Finance· 1 day ago"FDA grants IND clearance for Allay’s trial of post-surgical pain treatment" was originally created...
US FDA classifies recall of Teleflex's inflatable devices as 'most serious'
Reuters via Yahoo News· 15 hours agoTeleflex and its Arrow International unit reported 322 complaints, the FDA said on Thursday, adding...
Trouble for ecstasy? What MDMA’s FDA setback could mean for psychedelics
NPR· 1 day agohe says “What’s the FDA going to do? Are they going to oppose the vote made by the advisory committee?” Matthew Johnson thinks MDMA will eventually get ...
Why FDA Panel Rejected MDMA Therapy—And What’s Next For Psychedelic Medicine
Forbes· 1 day agoHigh hopes that psychedelic medicines were finally on the pathway to regulation were dashed last...