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 ...

“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 in 2016 granted accelerated approval to the FXR agonist as a second-line treatment for adults with PBC, either in ...

(Reuters) -The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver ...

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 ...

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 ...

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 ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market. US FDA declines full ...

According to the CRL, the FDA is continuing to assess the safety ... The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial ...

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 ...

GLP-1 stimulates the pancreas to reduce blood sugar levels, decreasing emptying of the stomach so people feel full longer and ... to shed weight. The FDA approval of Zepbound could also have ...