FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

The FDA and Hayward, California-based U.S. Trading ... Florida Department of Agriculture and Consumer Services collected a sample of the lily flowers and discovered that sulfites were present ...

The FDA approved the first generics of the direct oral anticoagulant rivaroxaban, the agency announced on Tuesday.

The FDA is reviewing the supplemental NDA for cabozantinib ... The Company is seeking approval for acute treatment of migraine with or without aura.

As of January 24, his job-approval ratio was 49.7 percent positive and 41.5 percent negative. As of March 3, it’s 48.0 percent positive and 47.8 percent negative, which means his net approval ...

The case, called Missouri et al. v. FDA, is a revamped version of a lawsuit filed by anti-abortion groups and doctors in 2023 seeking to block the Food and Drug Administration’s (FDA) approval ...

In a sample of 400 phase II trials that included 25,000 participants, a total of 4,045 patients (16.2%) received a treatment that advanced to FDA approval, reported Jonathan Kimmelman, PhD, of the ...

It noted at the time more countries would get access as regulators approved the feature, and the FDA was apparently the first to come through outside of Europe, boosting support to 15 countries.