Sumitomo Dainippon Pharma
Dasotraline (NDA)
FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
05/14/2020
Halozyme Therapeutics, Inc.
DARZALEX (BLA)
FDA decision on subcutaneous delivery of DARZALEX for patients with multiple myeloma.
05/12/2020
Sanofi
Isatuximab (BLA)
FDA decision on Isatuximab b for the treatment of patients with relapsed/refractory multiple myeloma
04/30/2020
United Therapeutics Corp
Trevyent (UTHR)
FDA decision on Trevyent for the treatment of pulmonary arterial hypertension
04/27/2020
Correvio Pharma Corp.
Trevyent (NDA)
FDA decision on Trevyent for the treatment of pulmonary arterial hypertension
04/27/2020
Neurocrine Biosciences Inc
Opicapone (NDA)
FDA decision on Opicapone as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.
04/26/2020
Sanofi
MenQuadfi (BLA)
FDA decision on MenQuadfi to prevent meningococcal meningitis
04/25/2020
AstraZeneca PLC
Trastuzumab deruxtecan (BLA)
FDA decision on Trastuzumab deruxtecan or treatment of patients with HER2-positive metastatic breast cancer
04/17/2020
Eli Lilly And Co.
Empagliflozin/Iinagliptin/Metformin Triple Combination Tablet (NDA)
FDA decision on the triple combination tablet for adults with Type 2 Diabetes
04/04/2020
Celgene Corporation
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with very low- to intermediate-risk MDS-associated anemia
04/04/2020
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with very low- to intermediate-risk MDS-associated anemia
04/04/2020
Rockwell Medical Technologies Inc
IV Triferic (NDA)
FDA decision on IV Triferic for iron deficiency in chronic kidney disease patients receiving hemodialysis
03/28/2020
IntelGenx Technologies Corp.
RIZAPORT VersaFilm (NDA)
FDA decision on RIZAPORT VersaFilm for the treatment of acute migraines
03/26/2020
Celgene Corporation
Ozanimod (NDA)
FDA decision on Ozanimod for Treatment of Relapsing Forms of Multiple Sclerosis
03/25/2020
Vertex Pharmaceuticals Inc.
VX-445 (elexacaftor), tezacaftor and ivacaftor triple therapy (NDA)
FDA decision on triple therapy to treat cystic fibrosis
03/19/2020
FDA approved the triple therapy, under brand name Trikafta, on October 21, 2019.