FDA
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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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.
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.
Tablet-Based Device Manager Provides Portable and Secure Wireless Programming of Medtronic BlueSync(TM) Devices
Dengvaxia is approved for dengue disease caused by serotypes 1-4 in people 9 through 16 years of age who are living in areas of the U.S. who have had a laboratory-documented previous infection.
Attain Stability(TM) Quad MRI SureScan(TM) Lead Designed for Precise Placement and Stability
This week has a number of approvals expected by the U.S. Food and Drug Administration. Let’s take a look.
In September 2018 a leap forward in treating burn victims was made with the approval of Avita Medical’s RECELL Autologous Cell Harvesting Device. The Food and Drug Administration (FDA) green lit the California-based company’s burn treatment device that uses a small amount of a patient’s own skin to prepare what is called Spray-On Skin Cells.
Bausch Health, former known as Valeant Pharmaceuticals International, announced that the U.S. Food and Drug Administration (FDA) had approved its Duobrii (halobetasol propionate and tazoretene) Lotion for plaque psoriasis.
Biom’up announced that the U.S. Food and Drug Administration approved the IDE application for HEMOSNOW, a hemostatic dry powder made from porcine collagen and bovine-derived chondroitin sulfate developed by the Company for managing minimal and mild levels of bleeding during surgical procedures.