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FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA that provides information on implementing the new program that was create...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.
Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines.
