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...
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...
