FDA approves Ascendis Pharma’s weekly Yuviwel for paediatric dwarfism

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

FDA to offer cash bonuses for faster drug reviews

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

FDA to offer bonus payments to staffers who complete speedy drug reviews

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

US FDA lifts clinical hold on Intellia's heart disease gene therapy trial

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

Pfizer CEO flags issues with FDA's vaccine leadership

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.

FDA Announces Recall of More Than 650,000 Plastic Water Bottles Produced Under 'Insanitary Conditions'

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

FDA proposes new treatment approval pathway for ultrarare diseases

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

UniQure Falls as FDA Seeks Controversial Gene Therapy Study

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

The FDA shifts the goalposts on rare disease drugs

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 ...

FDA to Give Staff Bonuses for Speeding Up Drug Reviews

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