Search results for "US FDA"

The recent avian flu pandemic that has affected American cow herds has not altered the safety of pasteurized milk, according to a Friday statement from the Food and Drug Administration (FDA). It happens one day after...

According to a new rule change by the Biden administration, retail pharmacies in the US can now dispense the abortion drug mifepristone. Mifepristone is currently only available in person from a medical professional as one of...

Drugmaker Roche had got Emergency Use Authorization from the U.S. Food and Drug Administration for a trial to rapidly detect whether a patient has SARS-CoV-2 or one of two forms of influenza, the company said today....

Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has...

News Hour: Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN®for the treatment of adults and children with hemophilia B. “We are excited about the approval...

News Hour: Novartis announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T-cell (CAR-T) therapy,...

News Hour: A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration (FDA), putting the Swiss drugmaker ahead of rivals working on similar cancer...

News Hour: Novartis has won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer’s Ibrance. The Swiss company has priced Kisqali...

News Hour: The U.S. Food and Drug Administration (FDA) has granted priority review to Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said on Thursday. The priority review covers...

News Hour: Portola Pharmaceuticals, Inc.® announced that the U.S. Food and Drug Administration (FDA) accepted Portola’s New Drug Application (NDA) granting priority review for betrixaban, an oral, once-daily Factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous...