The FDA has determined that the phase 3 SIERRA trial conducted by Actinium Pharmaceuticals is not adequate to support a BLA filing for Iomab-B to treat patients with active relapsed…

This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was…

In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for…

CDER’s Office of New Drugs (OND) touted accomplishments by the research program it launched in 2019 to address knowledge gaps identified during regulatory reviews. Source: Drug Industry Daily

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…