Food and Drug Administration (FDA)
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The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
The U.S. Food and Drug Administration issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
To help kick off the holiday season, BioSpace gave this Christmas classic a unique biopharma spin.
Shares of France-based Ipsen are down more than 2% on the Euronext Paris exchange after the U.S. Food and Drug Administration placed a partial clinical hold on its investigational treatment for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
According to PhRMA, there are 264 vaccines in development to prevent and treat diseases. These include infectious diseases (137), cancer (101), allergies (10), autoimmune disease (8) and Alzheimer’s disease (4).
In March, the FDA issued a Complete Response Letter for Zynquista as a treatment for type 1 diabetes.
Previously, Toujeo was approved only for adults aged 18 years and older.
Tetra Bio-Pharma Inc., announced that the U.S. Food and Drug Administration has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™, for the treatment of uncontrolled pain in advanced cancer patients.
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