home

European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe

BLAmgen2015-12-21 14:57 Read   543

Amgen today announced that the European Commission has approved the use of IMLYGIC™ (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease. IMLYGIC is the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase 3 clinical trial.

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

BLFDA2015-12-09 11:12 Read   316

Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.

FDA approves first recombinant von Willebrand factor to treat bleeding episodes

BLFDA2015-12-09 10:36 Read   313

FDA today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD).