FDA Approves First Prostate Cancer Hormone Treatment
Today (12/21) the U.S. Food and Drug Administration (FDA) approved the first oral treatment for prostate cancer, a disease that affects on average one in every nine men. Orgovyx, created by Myovant, was created to treat advanced prostate cancer cases by blocking the...
Moderna COVID-19 Vaccine Receives FDA Emergency Use Authorization
On Friday (12/18) The U.S Food and Drug Administration granted Moderna Emergency Use Authorization for their COVID-19 vaccine in adults over 18 years old. In addition to Pfizer’s vaccine, the U.S government agreed to purchase 200 million doses from Moderna which will...
GlaxoSmithKline, MacroGenics Inc. and More Receive FDA Approvals
The U.S. Food and Drug Administration (FDA) had many approvals this week including a treatment created by GlaxSmithKline for Lupus Nephritis in adults, one of the most common autoimmune diseases. The FDA approval for GlaxoSmithKline was historic, as Benlysta is the...
Jet 7 Xtra Flex Catheter for Stroke Patients Recalled by Penumbra
Following the close of the market on Tuesday, Penumbra announced the U.S. Food and Drug Administration (FDA) advised recall of their catheter device resulting from 14 reported patient deaths, among other patient hemorrhages,...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test
On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
Pre-Market Review Option Rolled Out by FDA for 510k Clearance
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...