Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...

Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of phase one clinical trials and applications to the FDA at the end of the ...

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...

A Food and Drug Administration official involved in scrutinizing the safety of antidepressants, COVID-19 vaccines and other ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

Eligible patients in the expanded access program will be able to receive daraxonrasib from their healthcare provider.

Evansville, Ind. — Lavender Timmons popped the trunk of her weather-beaten 2007 Ford Focus parked near the city’s homeless shelter. Regulars gathered around, including one drug user who in the past ...

BOSTON (SHNS) – Health officials are rolling out regulations to implement a 2024 law legalizing the use of certified medication aides in long-term care facilities, rules that supporters say will help ...

Many of the directions included in the order will be familiar to those who watched drug pricing policy closely during the first Trump Administration, though the portions of the order relating to the ...