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FDA BRIEFS

FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy

FDA notes idiopathic epilepsy is a type of seizure disorder without a known cause. KBroVet-CA1 works by stabilizing neurons in the central nervous system to reduce the likelihood of having a seizure.

EndoRotor System: FDA Authorizes Marketing of New Device Designed to Remove Dead Pancreatic Tissue

"This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis," said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA's Center for Devices and Radiological Health.

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

FDA Approves 1st of its Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses.

FDA Launches Portal for Submission of Orphan Drug Designation Requests

FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D. "Developing a treatment for a rare disease can be complex. Collaboration, including through the use of technology, is critical to supporting and facilitating efficient processes for these types of necessary treatments.

Emergency Use Authorizations: FDA’s Ongoing Commitment to Transparency for COVID-19

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D

Medicrea International Acquisition Completed

This is Medtronic's seventh acquisition completed in 2020 and furthers Medtronic's strategic expansion into AI, machine learning, and predictive analytics.

COVID-19 Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells.