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FDA Staff Proposes Narrow Approval for Lilly’s Alzheimer’s Drug
Bloomberg· 3 days agoUS drug regulatory staffers are considering a more targeted approval for Eli Lilly & Co.’s...
Eli Lilly’s Alzheimer’s drug to face safety, dosing scrutiny from FDA advisers
Market Watch· 2 days agoIn a briefing document prepared for the advisory committee, the FDA raised questions about a unique...
FDA Reviewers Question Patient Selection for Alzheimer's Drug Candidate
MedPage Today· 4 days agoIf approved, donanemab will be the third amyloid-targeted drug to come to market: the first being...
FDA Reverses Juul Ban. What Comes Next?
InvestorPlace· 2 days agoThe FDA lifted its ban on Juul’s products after conducting additional studies of the products. Also flavoring the FDA’s</ ...
FDA approves Geron’s RYTELO for MDS associated anaemia
Pharmaceutical Technology via Yahoo Finance· 3 days agoThe US Food and Drug Administration (FDA) has granted approval for Geron’s RYTELO (imetelstat) for...
FDA vaccine advisers vote unanimously in favor of updated Covid-19 shot for fall
CNN.com· 4 days agoThe committee voted on the question, “For the 2024-2025 Formula of COVID-19 vaccines in the U.S.,...
US FDA expands GSK's RSV vaccine approval to adults aged 50 to 59
Reuters via Yahoo News· 2 days ago(Reuters) -The U.S. Food and Drug Administration approved the expanded use of GSK's respiratory...
FDA lays out donanemab concerns ahead of meeting, as Lilly vigorously defends safety
FierceBiotech· 3 days agoThe docs for Eli Lilly’s donanemab advisory committee meeting are in: the FDA has raised concerns...
US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug
Reuters via Yahoo News· 3 days agoAn FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on...
FDA clears GSK's RSV vaccine for adults ages 50-59
United Press International via Yahoo News· 1 day agoThe U.S. Food and Drug Administration on Friday approved GSK's respiratory syncytial virus vaccine for high-risk adults ages 50 to 59, expanding the...