President Trump begins taking an investigational drug cocktail from Regeneron after being confirmed to be infected with Covid-19.
FDA renews and expands its use of Certara biosimulation software in 11 agency divisions and offices.
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Federal Register notice: FDA makes available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses Biopharmaceutics App...
Federal Register notice: FDA makes available a draft guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation...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.