Six Epstein Becker Green attorneys analyze an FDA final guidance on informed consent that leaves the door open to future changes as part of harmonizat...
X4 Pharmaceuticals files an NDA for a once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (warts, hypogammaglobulinemia, inf...
Roche says recent data from its Phase 3 ALINA study evaluating Alecensa (alectinib) compared with platinum-based chemotherapy met its primary endpoint...
FDA posts a final guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex (MAC): Developing Drugs for T...
FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA that provides information on implementing the new program that was create...
Federal Register notice: FDA makes available a guidance to describe that enforcement policies will be extended for an additional year for certain whol...
FDA clears a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to report an additional 4...
FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing operations.
