FDA Approvals

FDA okays biosimilar for several cancersWhile FDA has approved a handful of biosimilar drugs, the agency just approved the first biosimilar that treats a variety of types of cancer.
Blockbuster diabetes drug earns heart indicationA top-selling diabetes drug has gained a cardiovascular indication from FDA.
FDA okays targeted leukemia treatmentFDA approved a targeted new drug to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA approves novel leukemia, hepatitis C drugsFDA approved the first treatment for patients with a certain type of acute myeloid leukemia, as well as 2 new drugs to treat hepatitis C.
New universal companion diagnostic paves the way for precision oncologyFDA approves new diagnostic test for non-small cell lung cancer.
New antibiotic approved for acute bacterial skin infectionsFDA approved the use of a new fluoroquinolone antibiotic to treat ABSSSI.
FDA approves Bayer’s Bluetooth-enabled auto-injector for multiple sclerosisFDA has approved a supplemental Biologics License Application (sBLA) for Bayer’s myBETAapp and BETACONNECT Navigator for multiple sclerosis (MS) patients
FDA approves EpiPen rivalAdamis’ epinephrine injection promises to be a lower-cost alterative to EpiPen.
FDA approves first generic Truvada for HIVThe first generic Truvada for treating and preventing HIV will be available, but when?
FDA gives once-daily HIV therapy go-aheadFDA approves Isentress at a higher dose for HIV-1 infected patients.