FDA approves an expanded indication for Serviers Tibsovo plus a companion diagnostic test to identify patients for the new indication.
The 2nd Circuit Appeals Court says antitrust suits alleging that Takeda illegally delayed generic entry of its diabetes drug Actos can continue.
FDA clears a Fuse Medical 510(k) for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert.
FDA releases an FDA-483 with 10 observations from an inspection at the Fujifilm Diosynth Biotechnologies drug substance manufacturing facility.
FDA issues a Warning Letter to Invisi Smart Technologies (United Kingdom) over its Invisi Smart Mask for sale in the U.S. without a cleared 510(k).
Amneal Pharmaceuticals says it will file an NDA for IPX-203 in mid-2022, after reporting positive topline results from a Phase 3 clinical trial that e...
Federal Register notice: FDA announces that beginning 3/1/2022 it will reject Electronic Common Technical Document submissions that fail validations 1...
Federal Register notice: FDA seeks comments on an information collection extension entitled Environmental Impact Considerations (OMB Control Number 09...