FDA issues a guidance on clinical endpoints to demonstrate the effectiveness of drugs indicated to treat opioid use disorder.
FDA publishes guidances on developing drugs and biologics for adjuvant treatment of two types of cancer.
Federal Register notice: FDA makes available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses Biopharmaceutics App...
Federal Register notice: FDA makes available a draft guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation...
The 3rd Circuit Court of Appeals says a Pennsylvania federal court erred in portions of its decision in a case involving AndroGel marketing brought by...
Two House Oversight Committee reports say excessive drug company profits are the primary driver of higher prescription drug prices.
Attorney Stephen McConnell says the Massachusetts federal court is calling for Congress and FDA to reconsider the statutory and regulatory basis for p...
FDA lifts a clinical hold against Solid Biosciences IGNITE DMD Phase 1/2 clinical trial involving SGT-001, a novel adeno-associated viral vector-media...