Dynavax Technologies Corp
FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
Spectrum Pharmaceuticals Inc
FDA decision on EOquin for the treatment of non-invasive bladder cancer
Lexicon Pharmaceuticals Inc.
Telotristat Etiprate (NDA)
FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
Valeant Pharmaceuticals International
FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
Gilead Sciences Inc.
Tenofovir Alafenamide (TAF) (NDA)
FDA decision on TAF for treatment of chronic hepatitis B
FDA decision on Enbrel for the expanded use to treat pediatric patients with chronic severe plaque psoriasis.
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis
FDA decision on Sarilumab for the treatment of patients with rheumatoid arthritis.
FDA decision on Sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis
FDA decision on XTANDI in metastatic castration-resistant prostate cancer with data from head-to-head studies of Enzalutamide Vs Bicalutamide
OPKO Health Inc.
RAYALDEE (NDA Resubmission)
FDA decision on RAYALDEE for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 CKD and vitamin D insufficiency.
FDA approved RAYALDEE to treat secondary hyperparathyroidism with Vitamin D Insufficiency in Stage 3-4 CKD on Jun.21, 2016
Roche Holding AG
FDA decision on Atezolizumab for the treatment of specific type of lung cancer
SER120 (low-dose desmopressin nasal spray) NDA
FDA panel to review SER120 for the treatment of adult onset nocturia
FDA decision on AC-170 for the treatment of ocular itching associated with allergic conjunctivitis
ARYMO ER (NDA)
FDA decision on ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate