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...
GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the screw that secures the door becoming loose.
FDA issues a partial clinical hold on a BioNTech and OncoC4, Phase 3 trial that is assessing gotistobart in non-small cell lung cancer.
FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could support a determina...
FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committee 10-1 vote not to r...
FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy for treating advanced ...
FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
