Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010.
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
While the FDA has flip-flopped on whether to review Moderna’s combination influenza and COVID-19 vaccine, it’s full speed ahead for the mRNA shot in Europe. | While the FDA has flip-flopped on whether ...
Lithuania has demonstrated that it regards historical distortion as sufficiently serious to warrant criminal enforcement. It ...
With the CHMP affirmation, Moderna is on course to get EU approval for its fourth vaccine product and break new ground in ...
Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
Addressing reliable, accurate, and fast-acting voltage supervision that enables the reliable deployment of next-generation DC ...
The FDA application is supported by data from the Phase 3 evERA Breast Cancer study. The trial results showed that the combination of giredestrant and Afinitor reduced the risk of disease progression ...
NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this ...
NEWARK, CA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) (“Protagonist” or “the Company”) today reported financial results for the fourth quarter and full year ended ...
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a ...
A structured pathway supports individualized RNA-based and genome-editing therapeutics when ultra-rare prevalence precludes ...
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