FDA posts a draft guidance on generic naloxone hydrochloride nasal spray entitled Draft Guidance on Naloxone Hydrochloride.
FDA and Basilea Pharmaceutica reach agreement on Special Protocol Assessments (SPAs) for two planned Phase 3 clinical studies evaluating the companys ...
Rep. Steve Stivers (R-OH) reintroduces the Speeding Access to Already Approved Pharmaceuticals Act that would require FDA to expedite the review of ph...
FDA grants Aldeyra Therapeutics an orphan drug designation for ADX-102 and its use in treating congenital ichthyosis, a severe skin disease characteri...
FDA posts a transcript of a 3/17 Ophthalmic Medical Devices Panel meeting that discussed and made recommendations regarding the potential risks of mis...
FDA and the European Medicines Agency say their evaluation of a pilot program to parallel assessment of applications with Quality by Design elements p...
FDA restricts the use of codeine and tramadol medicines in children due to ongoing concern about serious risks, including slowed or difficult breathin...