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FDA to vaccinemakers: Updated COVID shots should target KP.2 variant
Becker’s Hospital Review· 11 hours agoThe FDA is now advising manufacturers to develop the 2024-2025 COVID-19 vaccines using the KP.2 strain for the formula, the agency announced June 13. The update comes just ...
FDA issues 510(k) clearance for Getinge’s Talis +ACG software
Medical Device Network via Yahoo Finance· 1 day agoMedtech company Getinge has obtained 510(k) clearance from the US Food and Drug Administration (FDA)...
FDA took months to react to complaint about Michigan infant formula factory, audit finds
MLive.com· 7 hours agoThe U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint...
FDA panel votes unanimously for Eli Lilly's Alzheimer's treatment
Yahoo Finance· 4 days agoAn FDA panel voted 11-0 Monday to recommend the use of Eli Lilly's (LLY) early-stage Alzheimer's...
FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans
AOL· 1 day agoA U.S. Food and Drug Administration (FDA) panel rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care. On June 4, the ...
Seasoning recall update as FDA sets most severe level
Newsweek· 1 day agoThe U.S. Food and Drug Administration (FDA) has issued its most severe type of food recall after...
FDA elevates Medline recall of endotracheal ventilator tubes
FierceBiotech· 1 day agoThe FDA has elevated a recall from Medline that has seen the device distributor pull tens of...
Biogen (BIIB) & Eisai's Leqembi sBLA Gets FDA Acceptance
Zacks via Yahoo Finance· 4 days agoFDA accepts Biogen's (BIIB) partner Eisai's sBLA for a maintenance intravenous dosing version of...
FDA approves AstraZeneca’s Farxiga for paediatric T2D patients
Pharmaceutical Technology via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has granted approval for AstraZeneca's Farxiga...
FDA grants IND clearance for Allay’s trial of post-surgical pain treatment
Clinical Trials Arena via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has granted clearance to Allay Therapeutics’...