FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung cancer.
Federal Register notice: FDA makes available a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
Federal Register notice: FDA makes available a final guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.
Federal Register notice: FDA makes available a final guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neon...
FDA releases a guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. `
Gilead Sciences withdraws the accelerated approval for a Trodelvy (sacituzumab govitecan-hziy) indication for treating adult patients with locally adv...
FDA approves an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sleepiness in patients...
Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about risks when using it a...
