In its main clinical trial, mRNA-1010 was shown to be 26.6% more effective than the comparator flu shot in adults aged 50 ...

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

By Sneha S K Feb 10 (Reuters) - The U.S. Food and Drug Administration will not review Moderna's approval application for its ...

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called mRNA-1010.

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

The FDA said in its refusal letter that the company's approach to compare mRNA-1010 to an already licensed standard-dose ...

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 ...

Moderna requests meeting to discuss refusal as decision could have implications for all new and updated vaccines ...

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, ...

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...