The monoclonal antibody is the first non-factor, once-weekly treatment approved in the United States for hemophilia B.

The new drug would allow patients to produce the needed clotting protein for an extended period, reducing the need for ...

Patients suffering from hemophilia received a "meaningful" advancement on Friday when federal regulators approved the first ...

Both the liquid that comes in the dropper with COVID tests and the test strips themselves can degrade over time, said ...

The FDA will decide on new drugs for rosacea, AADC deficiency, breast cancer, transthyretin amyloid cardiomyopathy, and biliary tract cancer.

The U.S. Food and Drug Administration has approved Regeneron's Dupixent (dupilumab) as an add-on maintenance treatment for ...

The FDA said on Monday it has authorized the first over-the-counter flu and COVID-19 combination test for the public to use ...

The FDA reported that the test accurately identified 99% of negative COVID-19 samples and 92% of positive samples. For the flu, the test showed 99.9% accuracy for negative samples and 92.5% and 90.5% ...

The CDC is attempting to get the COVID-19 shot into more arms by asking physicians and pharmacists to recommend the updated ...

The U.S. Food and Drug Administration approved Pfizer's once-a-week injection for the two main types of a rare bleeding ...

Miplyffa is the first drug approved for treating associated neurological symptoms in adults and children 2 years and older. HealthDay News — The U.S. Food and Drug Administration has approved Miplyffa ...

FDA approves the biologics license application (BLA) that Dong-A submitted in 2023 for Imuldosa, a biosimilar referencing Stelara.