House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are strengthening or und...
FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission in a new era.
A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facility manufacturing the...
A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides asked FDA for access ...
FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nep...
FDA accepts for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy.
FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.
FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unapproved medical devices...
