Tag Archives: Approves

FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma

Print this page SUMMIT, N.J.–(BUSINESS WIRE) May 28, 2019 — Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This… Read More »

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters Print this page Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) Nayzilam (midazolam) nasal spray CIV, a benzodiazepine indicated… Read More »

FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients

Print this page April 30, 2019 — The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. “Direct-acting antiviral drugs reduce the amount of HCV in… Read More »