The One That Got Away: This Small Town Is Left in Limbo After Betting Big on GMO Salmon
AquaBounty GMO salmon was going to be the future of fish — and the future for one Ohio village that offered incentives to ...
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FDA Approves NDA for Gilead's new HIV Prevention Shot
Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...
JD Supra6h
FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care ...
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Medtronic seeks to expand MiniMed 780G label to type 2 diabetes, submits new CGM to FDA
Third-quarter results for Medtronic (NYSE:MDT) included a timeline for a planned label expansion for its automated insulin ...
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also ...
FiercePharma15h
Regulatory tracker: Europe approves CSL's HAE drug, Arcturus-partnered COVID vaccine
During the open-label extension phase of the study ... Leerink analysts said it would not be surprising if the FDA wanted to discuss the results during an advisory committee meeting.
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Alcohol labels should contain cancer risk warnings, says WHO
A new report from the WHO underscores an ‘urgent need for mandatory, standardized labeling on alcoholic beverages’ ...
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The Genius Leftovers-Labeling Trick We Wish We’d Known About Sooner
Fortunately, content creator Getty Stewart (@getgettys) shared a game-changing method for labeling leftovers and freezer ...