Janssen Research & Development submits a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovas...
FDA says it will publish early next year a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet...
FDA approves Sanofi-Aventis Admelog (insulin lispro injection), a Humalog follow-on and short-acting insulin indicated to improve control in blood sug...
FDA Review posts the latest Federal Register notices for the week ending 12/8/2017
FDA Review posts product approval summaries for the week ending 12/8/2017.
Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled Fostering Digital Health Innovation: Developing the Software Precertifi...
Federal Register notice: FDA announces a 3/15/2018 public meeting entitled Oncology Center of Excellence: Listening Session.
Mylan petitions FDA to require strict bioequivalence study designs for ANDA applicants seeking to market generic versions of GlaxoSmithKlines asthma t...