Food and Drug Administration (FDA)
NEWS
The new guidance should allow switches from branded products to biosimilars that are alike in safety and efficacy without prescriber approval.
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
Neuronascent Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for its proprietary oral therapeutic, NNI-362, to proceed into Phase 1 clinical testing in a healthy aged population.
Today has been marked by a wide range of life science and biopharma stories. Here’s a broader look at some of the top stories.
The Global Health Investment Fund (GHIF) and Medicines Development for Global Health (MDGH) announced the sale of MDGH’s Priority Review Voucher (PRV).
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
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