This edition of Quick Notes features an additional indication approval for Palforzia, phase 3 trial results for AstraZeneca’s Calquence, warning from FDA for compounded semaglutide and FDA approval of an…

The FDA has long erred on the side of extreme caution when it comes to sharing confidential commercial information and trade secrets out of fear it might violate federal law…

The FDA has developed an AI tool to help its drug application reviewers and researchers identify changes to adverse event (AE) terms made when a drug’s labeling is updated. Source:…

With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Source: Drug…

Despite a mostly lukewarm reception to phase 2/3 trial findings, the FDA’s Genetic Metabolic Diseases Advisory Committee voted 11-5 in support of approving Zevra Therapeutics’ arimoclomol for type C Niemann-Pick…

During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and…

A recently published study of new drugs approved by the FDA from 1995 to 2014 showed that sales of most products (75 percent) exceeded the industry-wide costs of development within…

In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier…

The FDA has approved Guardant’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. Source: Drug Industry…

This week, the FDA published notice of user fee rates for fiscal year 2025. Source: Drug Industry Daily