Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dutch Ophthalmics Tissueblue (brilliant blue g ...
Federal Register notice: FDA determines the regulatory review period for Esperion Therapeutics Nexletol (bempedoic acid), indicated as an adjunct to d...
AdvaMed asks FDA to consider adding more information to a draft guidance on ethical considerations for clinical investigations of medical products inv...
Two stakeholders comment on an FDA draft guidance on computer software assurance.
FDA approves Seagens Adcetris (brentuximab vedotin) for treating pediatric patients with previously untreated high risk classical Hodgkin lymphoma....
FDA refuses to file a BrainStorm Cell Therapeutics BLA for its NurOwn to treat ALS.
Yale University researchers say FDA should strengthen its regulatory approach to artificial intelligence products used in breast cancer screening.
Federal Register notice: FDA makes available a draft guidance entitled Sameness Evaluations in an ANDA Active Ingredients.
