Supplemental new drug application for nintedanib capsules (drug name OFEV), by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease
Read MoreJAN 11 AAC-DSRM
Cardiovascular Safety of Takeda’s Gout Drug, Uloric (febuxostat)
Read MoreAPR 24-25 AAC DSRM
sNDA for CELEBREX (celecoxib), by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial
Read MoreAPR 23 AAC
Baricitinib tablets, submitted by Eli Lilly and Company, proposed for the treatment of adult patients with moderately 5 to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreAUG 2 AAC
Janssen's sirukumab injection (proposed trade name PLIVENSIA) for certain patients with rheumatoid arthritis
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreAUG 2 AAC
Janssen's sirukumab injection (proposed trade name PLIVENSIA) for certain patients with rheumatoid arthritis
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreAUG 2 AAC
Janssen's sirukumab injection (proposed trade name PLIVENSIA) for certain patients with rheumatoid arthritis
Read MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
Read MoreJUL 12 AAC
Amgen's Biosimilar to AbbVie's Humira (adalimumab) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis
Read MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
Read MoreJUL 12 AAC
Desmopressin nasal spray by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia
Read MoreJuly 12 AAC
Amgen's Biosimilar to AbbVie's Humira (adalimumab) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis
Read MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
Read MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
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FEB 9 AAC
Celltrion's Remsima (CT- P13), a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab)
Read MoreFEB 9 AAC
Celltrion's Remsima (CT- P13), a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab)
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