FDA Approves NUWIQ to Treat Hemophilia A

The U.S. Food and Drug Administration ha approved Octapharma’s NUWIQ, antihemophilic factor (recombinant), an intravenous therapy for adults and children living with hemophilia A.

FDA Approves Belbuca Buccal Film for Chronic Pain

The U.S. Food and Drug Administration has approved Belbuca (buprenorphine) buccal film for patients with severe chronic pain.

FDA Approves First Combination Immunotherapy for Melanoma

The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of advanced melanoma.

FDA Approves First-in-Class Treatment of Melanoma

Hailed as a major advancement in the fight against skin cancer, the U.S. Food and Drug Administration (FDA) has approved a new immune-based therapy for treating metastatic melanoma.

First Factor X Deficiency Bleeding Disorder Therapy Is Approved

The U.S. Food and Drug Administration approved the first replacement therapy for hereditary factor X deficiency, coagulation factor X (Coagadex, Bio Products Laboratory), derived from human plasma.

Gammaplex Approved for PI Patients 2 Years and Older

The U.S. Food and DrugAdministration (FDA) approved BioProducts Laboratory’s Gammaplex(immune globulin intravenous [human]5% liquid) for pediatric patients 2 years of age and older who have primary immunodeficiency disease (PI).

Wilate Approved for Perioperative Management of Bleeding in VWD Patients

The U.S. Food and Drug Administration(FDA) has approved revised product labeling for Wilate (von Willebrand factor/coagulation factorVIII complex [human]) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease patients.

FDA Grants 12-Year Exclusivity to Flublok

The U.S. Food and Drug Administration(FDA) has granted exclusivity to Flublok influenza vaccine for a period of 12 years.

Recombinant IVIG Granted Orphan Drug Designation for CIDP

Pfizer (a licensee of Gliknik Inc.) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its recombinant intravenous immune globulin (IVIG)-mimetic drug
GL-2045 to treat chronic inflammatory demyelinating polyneuropathy (CIDP).

FDA Accepts BLA for CSL’s rIX-FP for Hemophilia B Patients

CSL Behring’s Biologics License Application for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin, rIX-FP, has been accepted for review by the U.S.