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

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

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

The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have ...

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

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 ...

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

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

The pharmaceutical industry is not the enemy,” writes Richard Hughes IV, who was Moderna’s VP for public policy when the ...

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

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent with previous feedback.

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