FDA pledges to move quickly against companies that mass-market illegal copycat drugs by portraying them as equivalent to agency-approved medicines, co...
A new spending package enacted this week includes two long-sought policy changes for FDA clarifying the scope of orphan drug exclusivity and easing l...
A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recomme...
FDA cites Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the companys active pharmaceutical ingredi...
FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patien...
FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat debilitating pulsatile...
FDA publishes for public comment an International Council for Harmonization draft guideline on patient preference studies involving drug characteristi...
Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following results fr...
