BioMarin’s Voxzogo (vosoritide) won FDA approval in paediatric achondroplasia in November 2021 and secured a label extension ...

The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete ...

March 2 (Reuters) - Intellia Therapeutics said on Monday the U.S. Food and Drug Administration has removed a clinical hold on ...

The U.S. Food and Drug Administration's (FDA) chief says the agency will begin offering bonuses to drug reviewers who ...

UniQure NV’s shares plunged after US regulators said the company should conduct another study of its Huntington’s disease ...

If you have any of the recalled water bottle products, you should not consume them. While the FDA did not elaborate on why ...

UniQure said Monday that plans to seek approval for its Huntington’s disease treatment with the Food and Drug Administration ...

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...

Pfizer CEO Albert Bourla said the company "has a problem" with the U.S. Food and Drug Administration's biologics and vaccines chief, Vinay Prasad.

Marty Makary appeared for Thursday an interview on CNBC to tout efforts under his leadership at the Food and Drug Administration to speed up approvals for treatments of rare diseases. Instead, he ...

The US Food and Drug Administration plans to give bonuses to scientific staff for speeding up drug reviews, according to an ...