FDA
This is after Larimar reported deaths in the highest dose levels of a nonhuman primate toxicology study.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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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.
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.