The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
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In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...
The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting ...
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 FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...
The patient count in an outbreak of infant botulism linked to ByHeart formula is continuing to increase, and federal ...
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