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  • Octapharma gets FDA approval for new product strengths of NUWIQ

    HOBOKEN, N.J. — Octapharma USA today announced that the U.S. Food and Drug Administration has approved new product strengths for NUWIQ. The move potentially reduces the number of vials needed for hemophilia A patients, the company said.

  • Upsher-Smith launches new website for Qudexy XR

    MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Monday announced the launch of its enhanced website for Qudexy XR (topiramate) extended-release capsules.

  • FDA approves Pfizer’s leukemia drug Besponsa

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug from Pfizer, Besponsa (inotuzumab ozogamicin). The drug is indicated to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, or ALL.

  • Lynzparza’s new tablet formulation gets FDA approval, expanded indication

    WILMINGTON, Del. — AstaZeneca and Merck’s Lynzparza (olaparib) tablets were approved by the Food and Drug Administration, as well as given an expanded indication by the regulatory agency.

  • Makers of first ALS drug in 22 years announce availability

    JERSEY CITY, N.J. — The first drug for ALS approved in 22 years is now available. Mitsubishi Tanabe Pharma America this week announced the introduction of its Radicava (edaravone), an intravenous treatment for ALS that the Food and Drug Administration approved on May 5.

  • FDA green-lights CMP Pharma’s CaroSpir

    SILVER SPRING, Md. — CMP Pharma on Monday announced that the Food and Drug Administration had approved its CaroSpir (spironolactone oral suspension, 25 mg/5ml). The company said it’s the only FDA-approved liquid dosage form of potassium-sparing diuretic spironolactone.

  • Teva gets FDA clearance for QVAR RediHaler

    SILVER SPRING, Md. — The Food and Drug Administration has approved Teva’s QVAR RediHaler (beclomethasone dipropionate HFA), the company announced Monday. The QVAR RediHaler is a breath-actuated inhaler for the maintenance of asthma as a prophylactic treatment in patients ages 4 years and older.

  • FDA approves Vyxeos for acute myeloid leukemia
    SILVER SPRING, Md. — A new treatment for certain types of acute myeloid leukemia has been cleared by the Food and Drug Administration. Jazz Pharmaceuticals’ Vyxeos was approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes
     
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