US FDA

The U.S. Food and Drug Administration declined to approve Merck and Japan-based Daiichi Sankyo’s lung cancer treatment, which belongs to a lucrative class of cancer therapies that work like “guided missiles”. The FDA cited findings from...

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....

Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its insomnia treatment in adult patients. The agency approved the drug, Dayvigo, in doses...

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...

GR2E Golden Rice, a provitamin-A biofortified rice variety, completed its third positive food safety evaluation, this time from the United States Food and Drug Administration (US FDA). In an official response received by the International Rice Research Institute (IRRI) on...

News Hour: Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. The FDA’s decision comes...

News Hour: The U.S. Food and Drug Administration (FDA) on Friday approved Pfizer Inc’s drug, Mylotarg, for certain patients with acute myeloid leukemia (AML). The drug was cleared to treat adults with newly diagnosed AML whose...

News Hour: Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment...

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...