FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.
FDA publishes a guidance to assist those involved with clinical trials in determining how to proceed during a disaster or public health emergency.
FDA commissioner Robert Califf tells a podcast that drug manufacturers have fought FDA efforts to encourage companies to produce more drugs when there...
FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they believe the Intarcia NDA for its ITCA 650 drug/device c...
Two attorneys say their review of drug preemption cases shows that the defense is demanding but can be attained.
FDA grants Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera.
Relmada Therapeutics says a Phase 3 trial in Major Depressive Disorder shows that patients treated daily with REL-1017 for up to one year experienced ...
Taysha Gene Therapies says it is discontinuing the development of its gene therapy TSHA-120 program as a treatment for giant axonal neuropathy after r...
