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

Setmelanotide is a melanocortin-4 receptor (MC4R) agonist designed to treat hyperphagia and obesity. Rhythm is evaluating setmelanotide in a global Phase 3 trial in patients with acquired hypothalamic ...

The treatment was approved by China’s National Medical Products Administration (NMPA) and is China's first, and the world’s ...

When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...

Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...

The end of compounded versions of weight-loss drugs is near, leaving patients scrambling for alternatives. Some “copycat” ...

Sooma Medical has received the approval of an investigational device exemption (IDE) from the US Food and Drug Administration ...

is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address ...

If you’re looking for an FDA-approved weight loss supplement that ... huperzine, saffron, theobromine, and bioperine. These ingredients work together to boost metabolism, burn fat, and improve ...

The Food and Drug Administration unexpectedly canceled an annual meeting of its advisers to update next season's influenza vaccines, an adviser on the panel and multiple officials tell CBS News ...

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 ...

The U.S. Food and Drug Administration first approved mifepristone in 2000. Data from a 2023 study found that medication abortion is used in well over half of abortions in the United States ...