Food and Drug Administration (FDA)
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The NDA was based on positive Phase III data that shows the once-a-month treatment is as effective as the daily standard of care.
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.
The makers of blood pressure medications can face estimated 2,000 lawsuits over the alleged carcinogen-tainted medications. Check here how much they cost.
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.
Plaque psoriasis is the most common type of psoriasis, caused by overproduction of skin cells. This causes inflamed, red lesions called plaques.
GenFit’s lead product candidate elafibranor snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration as a treatment for Primary Biliary Cholangitis (PBC) following strong Phase II results that demonstrated the safety and efficacy of the medication.
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.
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