The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

The Food and Drug Administration announced the approval of a new non-opioid pain medication this week, marking the first time ...

The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Ozempic Approval Expanded to Include T2D Patients ... patients as young as 1 year old experiencing fat malabsorption. FDA Clears Digestive Enzyme Cartridge RELiZORB for Kids as Young as 1 Year ...

The Food and Drug Administration approved Vertex Pharmaceuticals’ “Journavx” on Thursday, greenlighting the non-opioid ...

For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...

The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled bleeding or in those who require urgent surgery or invasive procedure.