FDA clears a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment.
Academic medical center researchers document gaps in demographic representation for older adults and black patients in cancer therapeutic pre- and pos...
Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 a...
Pew Charitable Trusts calls on HHS to reinstate FDAs authority to require premarket reviews for laboratory-developed tests.
FDA says it is working with manufacturers of transmucosal immediate-release fentanyl products to ease provider and pharmacy recertification in a modif...
FDA grants priority review to a Takeda NDA for mobocertinib to treat some lung cancers.
Amgen agrees to an FDA-proposed post-marketing requirement to conduct a multi-center randomized clinical trial to compare the safety and efficacy of L...
A Compounding Pharmacy Foundation-funded report says FDA should ignore a National Academies report on the safety and efficacy of compounded hormones.