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 ...

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

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 ...

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

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

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

The heads of three early-stage companies shared lessons from going public in a challenging market for biotech stocks.

Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S.

With a sustained 7% annual growth rate, the CDMO sector reflects a fundamental shift in how modern medicines are brought to ...