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

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

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

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...

Mar 29 2022 The U.S. Food and Drug Administration(FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna...

Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...

Mar 25 2022 On March 25, 2022, FDA limits use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant....

Mar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...

Mar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...

Mar 15 2022 On March 15 2022, The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol...

Mar 14 2022 On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022. OTC...

Mar 08 2022 March 01 2022, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical...

Mar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...

Mar 07 2022 Date: March 29, 2022 Time: 2:00 PM - 3:00 PM ET ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the...

Mar 01 2022 FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow...

Feb 28 2022 [2/25/2022] The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for...

Feb 28 2022 [2/24/2022] The U.S. Food and Drug Administration has revised the emergency use authorization for Evusheld (tixagevimab...

Feb 24 2022 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death...

Feb 22 2022 Pictured are circulars at a Family Dollar store in Chicago on March 3, 2020.Daniel Acker/Bloomberg/Getty Images Today, the...