Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a…

Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he…

The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a…

The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials…

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of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1.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 The long-awaited draft guidance on diversity in clinical trials was also published.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…