pies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation an
Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.
Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects
Pacific Ketamine Institute (PKI), a pioneer in treating depression, PTSD, and chronic pain using Ketamine-based treatments, announced today that it has officially started offering patients the new FDA-approved esketamine nasal spray, SPRAVATO™, at its flagship Beverly Hills treatment center.
Approval represents first and only FDA-approved biologic indicated for newly diagnosed patients who are eligible for a stem cell transplant
MC2 Therapeutics, a late clinical-stage pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Wynzora™ Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis.
Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, received clearance from the Food and Drug Administration (FDA) for PhoenixMD's Investigational New Drug (IND) application for its proprietary PMD-026.
Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago.
Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on aging research, today announced the acceptance of an Investigational New Drug ("IND") application by the Food and Drug Administration (FDA) to evaluate the efficacy of BASIS™ for the prevention of acute kidney injury (AKI) in surgical cardiac patients.
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.
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).
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
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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.
Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.
NDA Submitted under the FDA’s Accelerated Approval Program