Blueprint Medicines begins a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in patients with RET fusion...
Recipharm staffers discuss the advantages of a quality by design approach to drug manufacturing.
Calling FDAs regulatory system woefully out of date, a Heartland Institute post discusses recent agency executives comments about their staffing chall...
FDA approves Mercks Keytruda (pembrolizumab) for treating certain patients with non-muscle invasive bladder cancer.
FDA grants 3Derm Systems a breakthrough device designation for its 3DermSpot, an algorithm that uses artificial intelligence and highly standardized s...
Minneapolis Heart Institute researchers fault FDA and the medical device industry for not better managing and communicating about medical device produ...
CDER Emerging Technology Team director Sau Lee explains how the program aids industry to innovate and more easily meet regulatory requirements.
Harvard Medical School researchers say policymakers should be looking at high-cost drugs to determine why there arent more generic or biosimilar versi...