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

July 24 (Reuters) - The U.S. Food and Drug Administration on Friday approved a nonprescription, fixed-dose pill that combines ...

In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the first ...

The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions ...

The approval establishes LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment ...

First OTC fixed-dose combination product to pair acetaminophen with naproxen sodium ...

How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...

The vote is non-binding and will still need sign off from the FDA.

Shares of Outlook Therapeutics posted wide swings as the Food and Drug Administration approved the company's Lytenava for treatment of neovascular age-related macular degeneration.

Replimune said it plans to resubmit its melanoma drug for approval following two earlier rejections. The move follows the departure of Food and Drug Administration Commissioner Marty Makary. Replimune ...

A new type of pain relief option, combining two popular medications, has been approved by the FDA. Here's what to know. (AP ...