The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer’s patients and advocates have been lobbying the federal government for months after ...

Cinryze is the first product to be approved by the FDA for the routine prophylaxis of ... be fully trained and productive enough to carry a full workload because of the complexity of the work ...

Pfizer's two-dose Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) - the first jab to be licensed in the nation. The vaccine had initially been given ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

Although the FDA has corrected much of their staffing problem, they are still underfunded and overworked.” Nevertheless, the percentage of total approvals for the year that were for new ...

“We know it works, so maybe this full FDA approval for those 16 and older will be enough to take those people who were hesitant and make them feel comfortable enough to go get vaccinated.

The FDA has convened a meeting of an advisory committee in June to consider the bid by Eisai and Biogen to convert their accelerated approval of Alzheimer’s disease therapy Leqembi into a full ...

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short. Intercept on Tuesday revealed that it received a complete response letter from the FDA ...

AstraZeneca faces challenges in securing full FDA approval for Andexxa, its anticoagulant reversal therapy, due to safety ...

Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing ...

The UbiqVue 2A multi-parameter system biosensor is worn on the chest and collects biodata across 13 monitored parameters.