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FDA Chief on H5N1: 'We Have to Be Ready'
MedPage Today· 5 days agoFDA Commissioner Robert Califf, MD, described his agency's role in helping to prevent a wider outbreak of H5N1 avian influenza during a hearing of the...
FDA issues recall for diabetes app after over 200 reported injuries
Popular Science via Yahoo News· 3 days agoThe US Food and Drug Administration issued a software recall after a defective diabetes management...
FDA delays decision on Moderna RSV vaccine
BioPharma Dive via Yahoo Finance· 3 days agoThe regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
FDA tells providers to stop using Getinge heart devices
MedTech Dive via Yahoo Finance· 4 days agoGetinge has initiated 20 recalls related to problems with balloon pumps and cardiopulmonary bypass...
FDA urges providers to ‘transition away’ from Getinge cardiovascular life support pumps
FierceBiotech· 3 days agoFollowing 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life...
FDA chief says feds are preparing for low probability of bird flu moving to humans
North Dakota Monitor via Yahoo News· 4 days agoFood and Drug Administration said at a congressional hearing Wednesday the agency is preparing for...
FDA Roundup: May 10, 2024
Fort Wayne Journal Gazette· 2 days agoOn Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices ...
4C Medical’s AltaValve gains dual breakthrough designations from FDA
Medical Device Network via Yahoo Finance· 4 days ago4C Medical Technologies has secured dual breakthrough device designations from the US Food and Drug...
FDA sets date for advisory meeting on Lilly’s closely watched Alzheimer’s drug
BioPharma Dive via Yahoo Finance· 6 days agoThe advisory committee meeting is scheduled for June 10. During it, experts in the fields of...
Can-Fite receives FDA IND clearance for Phase IIb MASH treatment trial
Clinical Trials Arena via Yahoo Finance· 3 days agoCan-Fite BioPharma has obtained Investigational New Drug (IND) clearance from the US Food and Drug...