FDA lifts a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma.
FDA describes the interim communications process it will use for issues it finds when reviewing records or other information requested in lieu or in a...
FDA acting commissioner Janet Woodcock tells the Food and Drug Law Institutes annual meeting that the agency is at a critical inflection point in the ...
FDA issues a final guidance on master protocols for Covid-19 drugs and biologics.
FDA and the Medical Device Innovation Consortium announce a partnership with Booz Allen Hamilton to establish a benchmark of the medical device indust...
In a rare step, FDA publicly corrects CytoDyn misinformation about an investigational therapy for treating Covid-19 patients.
FDA posts a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency...
Two FDA officials update stakeholders online about agency efforts to improve its stakeholder and outside expert interactions to advance regulatory sci...