News MSD claims two national priority vouchers; report The next two discretionary priority vouchers to be awarded by the FDA are reported to be heading for two MSD drug candidates.
R&D FDA’s emerging framework to reduce animal testing: Implicati... Exploring the strategic shift toward reducing reliance on non-human primates (NHPs) and other animal species in R&D.
News Antibiotic is first approval in FDA national priority scheme FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.
News FDA set to raise bar for clinical trials of CAR-T therapies The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.
News FDA reveals real-world pilot for digital health tools The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.
News FDA could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
News Ambros' $125m for pain disorder drug, and other financings Our latest crop of biofinancings has nine-figure rounds for Ambros, Atavistik, Orum, and Addition, with Link Cell and Aeovian also raising new funds.
Sales & Marketing Sponsored How to meet your physicians where they are online A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.
