FDA approves a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two years of age and olde...
FDA approves Roches cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZenecas Iressa (gefitinib) in ...
FDA approves a Kala Pharmaceuticals NDA for Inveltys (loteprednol etabonate ophthalmic suspension) 1% for treating post-operative inflammation and pai...
FDA publishes a draft osteoarthritis medical product development guidance.
FDA contracts with the National Academies to advance development of opioid prescribing evidence-based guidelines.
The 3rd Circuit Appeals Court upholds a lower court ruling dismissing a whistleblower suit brought by the federal government and several states agains...
FDA issues Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding in women with uteri...
Federal Register notice: FDA announces a 10/19 public meeting entitled Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Contro...