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When there is a shortage of FDA-approved, brand-name medication – like with GLP-1 drugs Ozempic and Wegovy – the FDA says it allows compounding pharmacies to make alternative medications that ...
The updated vaccines from Pfizer and Moderna for people ages 6 months and older come amid a summer surge in COVID-19 cases across the U.S. Walgreens and CVS, two of the largest chains, previously ...
On Friday, Moderna Inc. (NASDAQ:MRNA) announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1. The submission is ...
The FDA on Monday once again granted tentative approval to yutrepia for PAH, as well as for PH-ILD, after the health regulator said it was still reviewing Liquidia's marketing application in January.
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
The FDA had given accelerated approval for Elahere in Nov. 2022, based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Swiss-based ...
With only accelerated approval, the drug is only covered by Medicare if people are enrolled in a clinical trial. No date has been set on when the FDA could make a decision on Aduhelm’s full ...