FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.
FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynthen STING-agonist ant...
FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (fish oil triglyceride...
Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.
The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-reported outcomes tool ...
FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial visi...
Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapys use in all patients ...
