Even though another biosimilar to infliximab (Remicade) was approved by FDA in mid-December, it likely won’t be marketed in the United States.
FDA okays the first short-acting insulin approved as a “follow-on” product.
FDA recently approved a new diabetes medication, as well as a drug to treat severe asthma.
FDA approved a new cancer biomarker test that can detect genetic mutations in 324 genes and 2 genomic signatures in tumors.
FDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA approved the first drug in the United States that has a digital ingestion tracking system, which records when the medication was taken.
FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.
FDA approved the first test that detects the Zika virus in blood donations and living organ donations.
FDA approved a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
FDA approved the first continuous glucose monitoring system that allows for diabetes treatment decisions without requiring a fingerstick.