FDA Approves Adynovate to Treat Hemophilia A
The U.S. Food and Drug Administration has approved Baxalta’s Adynovate for use in hemophilia A patients aged 12 years and older.
FDA Approves Boosted Flu Vaccine for Older Adults
The U.S. Food and Drug Administration has approved Fluad (Seqirus), an influenza vaccine that contains the adjuvant MF59.
BabyBIG: Definitive Early Immunotherapy for Infant Botulism
Explore the history and trace the development of BabyBIG, the life-saving immunotherapy for infant botulism.
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.
CMS Announces Biosimilars Reimbursement Rule
The Centers for Medicare and Medicaid Services issued final rules detailing how it will pay for services provided to Medicare beneficiaries in 2016.
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.
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.