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FDA monitoring potential supply gap after children’s hospitals report concerns over neonatal nutrition access
FDA acts to safeguard availability of life-saving neonatal starter nutrition products
FDA cites concerns following planned shutdowns of two facilities supplying certain neonatal starter PN products
FDA has announced a recall of berries sold in 16 states for potential E. Coli contamination
FDA CRACKS DOWN ON COMPOUNDED GLP-1s
The FDA is warning telehealth firms and compounders over unapproved weight-loss drugs including semaglutide, tirzepatide and retatrutide. $HIMS
The agency says retatrutide and cagrilintide cannot legally be used in compounding, and has already warned companies marketing unapproved retatrutide directly to consumers.
As of May 31, the FDA had received 990 adverse-event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide.
The FDA is also flagging dosing errors, fraudulent labels, improper refrigeration during shipping and questionable foreign-made ingredients, while reiterating that compounded GLP-1s are not FDA-approved or reviewed for safety, effectiveness or quality before being marketed.
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FDA Authorizes Generic Ivermectin Shot To Prevent Screwworm
FDA’s recall of 13,000 Whole Foods dips, salsas, and guacamole products across 12 states is now at its highest risk level due to a possible salmonella contamination
FDA Authorizes Juul to Sell New E-Cigarette - WSJ
FDA Approves 3 New COVID-19 Vaccines
FDA APPROVES MOUNJARO TO REDUCE CARDIOVASCULAR RISK
Eli Lilly $LLY adds a cardiovascular indication for adults with type 2 diabetes at high risk of heart events. In the 13,299-patient SURPASS-CVOT trial, Mounjaro was non-inferior to Trulicity for cardiovascular death, heart attack and stroke, with a 0.92 hazard ratio. Superiority was not established.
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