Federal Register notice: FDA determines that Novartis Pharmaceuticals Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were not withdrawn for s...
Federal Register notice: FDA sends to OMB an information collection extension entitled Allegations of Regulatory Misconduct Voluntarily Submitted to t...
PhRMA suggests that FDA revise a draft guidance on QTc labeling to incorporate an International Council on Harmonization guideline.
Reporting positive data from a Phase 3 study on mirikizumab in Crohns disease, Eli Lilly says it will seek FDA approval for the drug next year.
Rep. Abigail Spanberger and 14 Democratic colleagues ask FDA and DEA for more information on their work to resolve shortages of ADHD medications.
FDA lifts a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patients with myotonic dy...
FDA grants MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastoma.
FDA says it will accept until 12/11 applications for its new Digital Health Technologies Advisory Committee.
