Drug News

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Top-Line phase III results for oral JAK inhibitor Baricitinib, plus topical corticosteroids in patients with moderate to severe atopic dermatitis.- Eli Lilly

Eli Lilly and Company and Incyte Corporation announced that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase...

Added 9 hours ago Drug news

Clearside Biomedical provides update for Xipere, a treatment of macular edema associated with non-infectious uveitis.

Clearside Biomedical, Inc. announced an update regarding the Company’s 505(b)(2) New Drug Application (NDA) for Xipere (triamcinolone acetonide suprachoroidal injectable...

Added 9 hours ago Drug news

ADMA Biologics, Inc. announces the commercial relaunch and its first commercial sales of Bivigam for primary humoral immunodeficiency.

ADMA Biologics, Inc. a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics...

Added 1 day ago Drug news

FDA issues recall for Sapien 3 Ultra delivery system in aortic stenosis.- Edwards Lifesciences

After issuing a recall for the Sapien 3 Ultra delivery system, from Edwards Lifesciences, in July 2019, the FDA now...

Added 1 day ago Drug news

NICE does not recommend Epidyolex as a treatment with clobazam for Dravet and Lennox-Gastaut syndromes.- GW Pharma

The National Institute of Health and Care Excellence ( NICE) issued draft guidance although Epidyolex (cannabidiol) has been CHMP recommended...

Added 2 days ago Drug news

Fosmetpantotenate fails in Phase III FORT study to treat pantothenate kinase-associated neurodegeneration.- Retrophin Inc.

Retrophin, Inc. announced that the Phase III FORT Study evaluating the safety and efficacy of fosmetpantotenate compared to placebo in...

Added 2 days ago Drug news

ATLAS-2M study met its primary endpoint for cabotegravir and rilpivirine administered every eight weeks compared to four-week administration. Viiv HealthCare

ViiV Healthcare, announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen...

Added 2 days ago Drug news

Data from phase III RELAX-AHF-2 trial of Reasanz in heart failure published in NEJM.- Novartis

Results from the phase III RELAX-AHF-2 trial of Reasanz (serelaxin), from Novartis, for the treatment of patients with acute heart...

Added 2 days ago Drug news

FDA accepts NDA for zanubrutinib to treat mantle cell lymphoma.- BeiGene Ltd.

BeiGene, Ltd. announced that the FDA has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of...

Added 2 days ago Drug news

Xtandi sNDA filed with FDA for metastatic hormone-sensitive prostate cancer.- Astellas + Pfizer

Astellas Pharma and Pfizer announced that the FDA has accepted for review the filing of a supplemental New Drug Application...

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