The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete ...
The U.S. Food and Drug Administration plans to give quarterly bonuses to scientific staff for quicker completion of drug ...
The Food and Drug Administration warning letter detailed unreported low blood sugar and a software change to correct for delayed glucose readings.
The US Food and Drug Administration plans to give bonuses to scientific staff for speeding up drug reviews, according to an ...
The nod allows Hernexeos (zongertinib) to be used as an initial treatment option for NSCLC with HER2-activating mutations in ...
The framework was released as draft guidance on February 23.
The blueberries, sold in four states and Canada, may contain Listeria, which can cause serious illness. The FDA designated ...
Today, the FDA granted accelerated approval to zongertinib (Hernexeos; Boehringer Ingelheim Pharmaceuticals, Inc.) for an expanded indication for adults with unresectable or metastatic non-squamous ...
The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...
The Food and Drug Administration aims to evaluate treatments for rare diseases based on plausible evidence that they would work — without requiring a clinical trial first.
The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...