FDA approves a Kala Pharmaceuticals NDA for Inveltys (loteprednol etabonate ophthalmic suspension) 1% for treating post-operative inflammation and pai...
FDA issues a complete response letter with recommendations for resubmitting Malinckrodys NDA for stannsoporfin.
Federal Register notice: FDA announces a 9/20 public meeting entitled Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspe...
FDA clears a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System.
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...