FDA grants Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial myopathies.
FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to include use in patients si...
Federal Register notice: FDA posts a list PMAs, and associated safety and effectiveness summaries, that have been approved from 10/1/2018 through 12/3...
A clinical trial data and safety monitoring board questions AstraZenecas data it presented in a press release about its Covid-19 vaccine.
Oramed says it is recruiting patients for a second Phase 3 study of its investigational oral insulin capsule to treat Type 2 diabetes in patients with...
Three major drug advocacy groups petition FDA not to authorize a drug importation program proposed by New Mexico.
Federal Register notice: FDA reopens the comment period for a 10/28 notice entitled The Drug Supply Chain Security Act Pilot Project Program and Enhan...
A petition asks FDA to open a docket and solicit comments on possible Boxed Warnings for Jakafi and other JAK inhibitors.