Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida ...

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially ...

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with ...

An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

Detailed results presented at a medical congress help reinforce analyst expectations the drug, called duvakitug, will be competitive with other Crohn’s, colitis medicines in testing.

Unlike traditional laboratories, MAKO Medical has disrupted the industry by integrating cutting-edge AI-driven diagnostics, at-home testing solutions, and direct-to-consumer healthcare options. This ...

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...

Chris Gibson, Recursion’s head, cited the role small business grants played in helping his company grow its business.

Prescription totals for Attruby, which is locked in a closely watched commercial battle with Pfizer’s tafamidis, have more ...

The pioneering gene therapy developer will be acquired by investment firms Carlyle Group and SK Capital for a fraction of ...

The FDA determined that Novo Nordisk’s obesity and diabetes drugs are no longer in short supply. Elsewhere, Concentra made a ...

Layoffs at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, one ...