accelerated approval

FDA: Rigorous Trials Needed for Accelerated Approval

Imagine you’re trying to win a race. You might think that taking a shortcut would be the quickest way to reach the finish line. But according to the U.S. health regulator, that’s not always the case when it comes to approving cancer drugs. The Food and Drug Administration (FDA) has proposed that developers of cancer […]

Published on March 24, 2023

FDA Panel Backs Accelerated Approval for ALS Drug

In a momentous move, a group of experts from the FDA have given their seal of approval to expedite the approval process for Biogen Inc’s potential breakthrough treatment for ALS, a devastating neurological disease famously associated with baseball legend Lou Gehrig. The thrilling decision comes after an intensive review of compelling evidence that suggests the […]

Published on March 23, 2023