Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Pr...
FDA approves a revised label for Ironwoods Linzess expanding the potential for off-label use in children under age 18.
Three Sidley Austin attorneys describe a Minnesota federal court decision rejecting a whistleblowers claims that Boston Scientific fraudulently induce...
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).