FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...

A long-running confirmatory trial of two of Sarepta Therapeutics’ Duchenne muscular dystrophy drugs has missed its main goal.

Shares of Sarepta Therapeutics Inc. plunged in extended trading Monday after the biotechnology company disclosed disappointing drug-trial data, which could lengthen the timeline of the regulatory ...

The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...

Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...

The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some ...

They found that the automated diabetes GLP-1 prior authorization proportion of all diabetes GLP-1 claims grew by 17.5 percentage points, or 39.6%, from October 2024 to July 2025.

Eli Lilly said on Thursday its experimental weight-loss pill met most criteria for the U.S. Food and Drug Administration's ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary ...

The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...