Reprocessed Urological Endoscopes Infection Issue
On April 1th, the U.S. Food and Drug Administration (FDA) announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible…
FDA
Two Revisions to Moderna COVID-19 Vaccine EUA
On April 1th, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of doses per vial available for the Moderna COVID-19…
FDA Approves Abecma To Treat Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not…
FDA Warns Companies Illegally Selling CBD Products
The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that…
Zealand Pharma Announces FDA Approval of Zegalogue (dasiglucagon)
Zealand Pharma announced on March 22, that the U.S. Food and Drug Administration (FDA) has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia…
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test
On March 17, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), the first SARS-CoV-2 diagnostic test…
Non-Viral Hepatitis Cases Possibly Linked to Bottled Alkaline Water
The FDA, along with the CDC and the Southern Nevada Health District is investigating a number of reports of acute non-viral hepatitis in the state…
Ivermectin Against COVID-19?
The US Food and Drug Administration (FDA) recently writes an article about a growing interest in a drug called ivermectin to treat humans with COVID-19….
FDA Authorizes T-Detect COVID Test
On March 5, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The…
FDA Authorizes First Robotically-Assisted Surgical Device
The U.S. Food and Drug Administration (FDA) has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate…