The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
The 22-year-old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems, and other ...
The Food and Drug Administration (FDA) granted traditional approval to Imdelltra (tarlatamab-dlle) for adult patients with ...
At long last, the Food and Drug Administration will remove a “black box warning” label required on the packaging of most ...
Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...
The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate ...
The FDA has granted 510(k) clearance and a label expansion for a transcranial magnetic stimulation device to treat patients ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...
Specifically, sponsors will be able to submit a question via email and agency staff will aim to respond within three business days by email. Since the pilot launched in October, the agency has ...
Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...
FDA Ghana has made significant progress in establishing good review practices, but key gaps, especially in timelines, process tracking, and stakeholder feedback—must be addressed to meet WHO-listed ...
The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ResearchAndMarkets.com's offering.
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