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, ...
Medpage Today on MSN19d
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 ...
WebMD12d
First Brain-Injected Gene Therapy Approved by FDA
The FDA has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called ...
FDA approves Kebilidi for aromatic L-amino acid decarboxylase deficiency
The U.S. Food and Drug Administration has approved PTC Therapeutics' Kebilidi (eladocagene exuparvovec-tneq) for the ...
Managed Healthcare Executive4d
FDA Approves New Imatinib Oral Solution
Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing ...
The Pharma Letter8d
FDA panel flags risks as AstraZeneca seeks full Andexxa approval
AstraZeneca faces challenges in securing full FDA approval for Andexxa, its anticoagulant reversal therapy, due to safety ...
BioSpace7d
BridgeBio Wins FDA Approval for ATTR-CM Drug, Launching Competition With Pfizer
BridgeBio secured approval for Attruby Friday, along with the all-important mortality benefit that could give the drug a ...
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 ...
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 ...
FiercePharma18d
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 ...
Monthly Prescribing Reference18d
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 ...