The Supreme Court unanimously ruled that the Department of Health and Human Services (HHS) can’t reduce its payment rates for only a certain group of hospitals — namely, 340B Drug…

An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021,…

Amylyx’s potentially pricey amyotrophic lateral sclerosis (ALS) drug AMX0035 can only be cost-effective if it costs no more than $18,200 per year — much less than Radicava, the only approved…

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 21-0, yesterday in favor of FDA emergency authorization for Moderna’s two-dose COVID-19 vaccine series in children between age six…

The importation of prescription drugs from outside the country for commercial and personal use could soon become legal. Source: Drug Industry Daily

The FDA’s Center for Drug Evaluation and Research (CDER) is looking past the pandemic in its current goals for 2022, says Director Patrizia Cavazzoni, focusing on initiatives on rare diseases,…

The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13 to 9 yesterday in favor of a bill reauthorizing FDA user fees, advancing the package for a floor vote.…

The FDA has asked for comments on updates to the International Council for Harmonization’s guideline on quality risk management, ICH Q9. Source: Drug Industry Daily

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 22-0, yesterday to recommend FDA authorization of Moderna’s two-dose primary series of its COVID-19 vaccine for children between the…

In a briefing document issued ahead of a two-day meeting by its vaccines advisory committee that begins today, the FDA indicated its support for Emergency Use Authorization (EUA) of the…