The Food and Drug Administration (FDA) has awarded Perspectum Inc $250,000 to qualify its proprietary biomarkers for NASH in collaboration with Dr. Naim Alkhouri at the Texas Liver Institute.
Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOxTM Bronchial RheoplastyTM system.
DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).
Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020
Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies
Sandoz Inc. is recalling two medications that treat cholesterol and high blood pressure because the bottles they were packaged in failed to meet child-resistant closure requirements.
The FDA is warning that certain Hepatitis C treatments can cause further damage to the livers of people with advanced cases of liver disease.
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease).
Omeros Remains On Track to Initiate the Submission Next Quarter
Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of Abicipar quarterly dosing regimen
Once daily Aczone® 7.5% Gel is proven to treat acne vulgaris in 12 week clinical studies
Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens that provides a combination of near, intermediate and distance vision.
The Coconut Coalition of the Americas (CCA), announced the launch of an initiative to make it clear that coconuts are not tree nut allergens.
Interstitial lung disease (ILD) is the leading cause of death among people with systemic sclerosis (SSc) or scleroderma
Designation Underscores Urgent Need for New Antifungals Targeting Multidrug-Resistant Pathogens
Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).
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The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.