The EU’s Committee for Medicinal Products for Human Use (CHMP) isn’t supporting two drugs intended to treat patients with amyotrophic lateral sclerosis (ALS) and Duchenne muscular — diseases that have…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…

Another Philips ventilator recall was deemed Class I by the FDA for an issue that has led to 15 reported injuries and one death. Source: Drug Industry Daily

The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine), the first inhaled maintenance chronic obstructive pulmonary disease (COPD) drug in more than two decades, and granted marketing authorization of a novel…

Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Source: Drug Industry…

This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list…

This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s…

Several Philips BiPAP devices and certain Baxter Life2000 ventilator systems are under FDA Class I recalls, the most serious type of recall, as use of the devices can result in…

Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday.…

Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them…