FDA
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.
Plaque psoriasis is the most common type of psoriasis, caused by overproduction of skin cells. This causes inflamed, red lesions called plaques.
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.
The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
Akorn secured approval for a post-operative eye drop, as well as a generic over-the-counter version of GSK’s Flonase.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure. It results in difficulties in breathing and increasing episodes of breathlessness.
Company on Track to Submit NDA to FDA in Mid-2019
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