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...
Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promising late-stage cand...
Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco for all approved uses...
