Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-released data from a P...
FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.
FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.
FDA approves an updated label for Eli Lillys Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque density in patients bein...
FDA requires and approves updates to the prescribing information for Pfizers Comirnaty Covid-19 mRNA vaccine and Modernas Spikevax Covid-19 mRNA vacci...
A Global Biodefense online post says FDAs sudden decision to halt clinical trials that send samples overseas for processing can hurt the nations biote...
FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory acute m...
Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...
