FDA approves first drug targeting polycythemia vera biology
The FDA approved weekly Mimrylo for adults with poorly controlled polycythemia vera, offering a new way to reduce phlebotomies while requiring close blood-count monitoring.
Drug Safety
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FDA proposes withdrawing TAVNEOS approval after trial-data and liver-injury findings
The FDA proposed withdrawing U.S. approval of TAVNEOS, a treatment for adults with severe ANCA-associated vasculitis, after identifying manipulated pivotal-trial results, undisclosed analyses and serious liver injuries.
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FDA Posts Nationwide Recall of Papaverine Injection After Visible Particles Found
The FDA posted a nationwide recall for one lot of papaverine injection after visible glass or paraformaldehyde particles were found in the prescription drug.
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FDA Proposes Drug-Facility Rules to Improve Supply-Chain Visibility
A proposed FDA rule would give regulators more information on distributed drug makers and certain foreign suppliers, but patients and pharmacies see no immediate change.