The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases

Coverage Analysis for Oncology SlidesDownload The post Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success appeared first on WCG. Source: Drug Industry Daily

FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets…

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products for the treatment of cancer. Specifically,…

FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg Source: FDA Press…

Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due…

This week, the FDA published three medical device classifications — clinical chemistry and clinical toxicology devices, gastroenterology-urology devices and immunology and microbiology devices. The agency also published draft strategy on…

Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations…

The FDA spells out how long it expects to take to review amendments to generic drug applications in a final guidance that reflects the agency’s commitments under the Generic Drug…