Nature24 天
2008 FDA drug approvals
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 ...
BBC3 年
Pfizer becomes first Covid vaccine to gain full FDA approval
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 Maui News3 年
Pfizer vaccine first to get full FDA approval
“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.
Medpage Today on MSN19 天
FDA Rejects Full Approval of Liver Disease Drug
The FDA in 2016 granted accelerated approval to the FXR agonist as a second-line treatment for adults with PBC, either in ...
来自MSN18 天
US FDA declines full approval for Intercept's liver disease drug
(Reuters) -The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver ...
pharmaphorum1 年
FDA advisors will look at full Leqembi approval in June
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 ...
Nature14 年
2009 FDA drug approvals
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 ...
朝日新聞社1 年
Alzheimer’s drug Leqembi has full FDA approval
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 ...
Business Insider India3 年
The FDA just fully approved Pfizer's COVID-19 vaccine in a move that could lead to more ...
Moderna has said it expects to finish its application for full approval with the FDA in August. The full approval covers people 16 years and older getting the Pfizer-BioNTech vaccine. It will ...
Monthly Prescribing Reference18 天
FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis
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 ...
FiercePharma18 天
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated ...
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 ...
Forbes1 年
FDA Approved A New Weight Loss Drug Zepbound. Here’s What To Know And Expect
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 ...