But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...