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...
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...
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...
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,...
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...
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...
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
Russia’s Sovereign Health Plan disclosed today (12/11) that Sputnik-V will be joining AstraZeneca in their pursuit for a COVID-19 vaccine. The joint vaccine production will enter clinical trial phases on adults 18 years and older by the...
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency’s (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that...
ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...
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