Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...

The FDA’s CBER issued a refusal-to-file letter for Moderna’s flu vaccine mRNA-1010.

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

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...

Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and HHS became more and more ...

The Food and Drug Administration last week refused to review Moderna’s application for its messenger RNA flu vaccine, in a ...

Moderna Inc. (NASDAQ: MRNA) shares declined sharply in after-hours trading on Tuesday after the biotechnology company ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

The FDA declined to review Moderna’s experimental flu vaccine over trial design concerns, despite no safety issues. The ...