The Maui News3y
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.
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
WebMD1d
FDA Approves New SVT Drug for Critical Care Use
The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe ...
FierceBiotech1d
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
BioSpace1d
FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...
Hosted on MSN7d
FDA-approved hypertension drug found to increase life expectancy
Researchers have discovered that a drug commonly used to treat hypertension can extend lifespan and slow down aging. The ...
BBC3y
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 ...
pharmaphorum1y
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 ...
朝日新聞社1y
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 ...
MedPage Today21d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary biliary cholangitis (PBC ...
Hosted on MSN21d
US FDA declines full approval for Intercept's liver disease drug
Ocaliva received the FDA's accelerated approval in 2016 to ... The panel voted 10-1 against full approval of the drug. (Reporting by Puyaan Singh and Bhanvi Satija in Bengaluru; Editing by Sriraj ...
FiercePharma21d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
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 ...