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.
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...
House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid for its reductions-...
A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing t...
FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients wit...
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...
