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...
CytRx Corp. and FDA reach an agreement to allow the company to submit a rolling 505(b)(2) NDA for aldoxorubicin in soft tissue sarcomas.
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...
Federal Register notice: FDA asks for comments on an information collection: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling...
AbbVie says two Phase 3 trials of an investigational polymerase inhibitor against cancer did not meet their primary endpoints.