The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...

Biologics represented 5% of the drugs prescribed in the U.S. in 2024, but they accounted for more than half of the country’s total prescription medicine spending, according to health data analysis ...

The Food and Drug Administration (FDA) granted traditional approval to Imdelltra (tarlatamab-dlle) for adult patients with ...

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 ...

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 ...

The FDA says eight more infants have been hospitalized in the outbreak, warning that recalled ByHeart formula is still ...

Congress advances legislation to expand Medicare coverage for multi-cancer early detection tests, aiming to save lives through innovative screenings and improved access for seniors nationwide.

Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...

The patient count in an outbreak of infant botulism linked to ByHeart formula is continuing to increase, and federal ...

“The best ideas in drug discovery were often blocked not by biology, but by synthesis,” Boiko told TechCrunch. Synthesis is ...

The US Food and Drug Administration is rolling out a new program to speed up drug reviews by emphasizing clearer, more frequent communication with companies, aided by a surge of new hires.