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FDA's Final Rule on Laboratory Developed Tests Comes with Controversy and Concerns | JD Supra
JD Supra· 6 days agoThe U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed ...
Is Eli Lilly Stock A Buy Or A Sell As FDA Plans Meeting To Discuss Alzheimer's Drug?
Investor's Business Daily· 3 days agoThe FDA has signed off on its tirzepatide in patients with type 2 diabetes and as a weight-loss drug...
FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries
USA TODAY via Yahoo News· 2 days agoThe U.S. Food and Drug Administration has issued a recall correction for an app that connects with an insulin pump due to a software issue that causes the ...
Can-Fite receives FDA IND clearance for Phase IIb MASH treatment trial
Clinical Trials Arena via Yahoo Finance· 2 days agoCan-Fite BioPharma has obtained Investigational New Drug (IND) clearance from the US Food and Drug ...
Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 5 days agoThe US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks ...
UPDATE 2-US FDA advises healthcare facilities to switch from Getinge's heart devices
Reuters via Yahoo Finance· 4 days agoThe U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices ...
US FDA panel to discuss Eli Lilly Alzheimer's drug on June 10
Reuters via Yahoo Finance· 5 days agoMay 7 (Reuters) - The U.S. Food and Drug Administration's panel of independent advisers will deliberate on June 10 on whether they should recommend approval ...
...Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; ... Committee Releases Drug...
JD Supra· 6 days agoFDA finalized a rule regulating LDTs as medical devices, and Senate Finance Committee leadership released a discussion draft on drug shortages. On April ...
US FDA panel to discuss Eli Lilly Alzheimer's drug on June 10
Reuters via Yahoo News· 5 days agoFood and Drug Administration's approval last year. Lilly's donanemab was declined accelerated...
BioAtla gets FDA nod for new cancer drug trial By Investing.com
Investing.com· 6 days agoBioAtla, Inc. (NASDAQ:BCAB), a biotechnology firm specializing in the development of antibody...