FDA publishes an updated guidance on standards for the interoperable exchange of information for tracing certain drugs under the Drug Supply Chain Sec...
FDA posts recommendations for healthcare providers, medical device manufacturers, and distributors on best practices in preparing for natural disaster...
FDA grants Xenex Disinfection Services a de novo marketing authorization for the companys LightStrike+ device, a broad-spectrum ultraviolet light robo...
Individuals and organizations opposed to using puberty blockers in gender identity treatment for minors ask FDA to take several steps to increase know...
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...
