Moderna Looks Outside US for Growth After FDA's Flu Shot Refusal

Moderna Projects More Growth Outside US After FDA Rejects Influenza Vaccine

Moderna executives on Feb. 13 said the company forecasts more growth outside the United States after the U.S. Food and Drug Administration declined to review Moderna’s application for its experimental vaccine against influenza. About 50 percent of revenue in 2026 is expected to come from outside the United States, compared to 38 percent in 2025, Moderna executives said in an earnings call. FDA official Dr. Vinay Prasad, in a letter made public r…

Moderna looks outside US for growth after FDA's flu shot refusal

FDA snubs mRNA flu vax, trial Lax. Big Pharma threatens American Jobs

FDA snubs mRNA flu vax, trial Lax. Big Pharma threatens American Jobs Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by White House. https://youtu.be/FUK7ptsWst0 By Greg Piper For years before he became

Why did the FDA decline Moderna's flu shot?

Regulators, scientists and industry react U.S. regulators notified Moderna that they will not accept the company’s application to license an mRNA based influenza vaccine for formal review. The agency said the company’s pivotal trial did not meet the standard of an "adequate and well‑controlled"…

Moderna vs FDA; Paul Hudson out at Sanofi; Why clinical trials are so costly; and more

Welcome back to Endpoints Weekly! A programming note: We won’t be sending our usual newsletters on Monday, Feb. 16. Our team will be off for Presidents’ Day. Our reporters closely followed several big updates this ...