Telehealth provider Hims & Hers said it will tell consumers they need to seek “alternative options on the commercial dosing,” ...

Ten of 11 children born with a rare form of congenital hearing loss experienced improvements after receiving the company’s ...

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

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

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

Detailed results presented at a medical congress help reinforce analyst expectations the drug, called duvakitug, will be ...

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

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

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

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

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

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