FDA Approvals

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.
First generic Strattera for ADHD approvedFDA has approved the first generic versions of Strattera (atomoxetine) for the treatment of attention deficit/hyperactivity disorder.
Combination pack approved for breast cancer treatmentFDA approves ribociclib plus letrozole to treat a subset of advanced breast cancer patients.
FDA expands cystic fibrosis treatmentFDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.
Immuno-oncology bladder drug wins approvalSoon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.