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

FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...

Posted: June 4, 2025 | Last updated: June 14, 2025 The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices.

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

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The FDA becomes involved before any new drug molecule is tested in humans. Here’s how upheaval at the agency appears to be affecting specific points in the approval process for new drugs.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.