Apr 29 2022 FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External...

Apr 28 2022 At-home COVID-19 tests safety FDA authorized at-home COVID-19 tests are safe to use when people follow the manufacturer’s...

Apr 27 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include...

Apr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...

Apr 19 2022 FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing...

Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...

Apr 12 2022 In the United States, successfully launching a product is as important as developing a new medical device. Let's take a look...

Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...

Apr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...

Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...