Microsoft has fixed a "remote code execution" vulnerability in Windows 11 Notepad that allowed attackers to execute local or ...

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. | The FDA specifically ...

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now ...

Moderna stock is rated Sell amid FDA setbacks for mRNA-1010, commoditized COVID/RSV sales, and cash burn. Read the analysis of MRNA to assess key risks now.

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

Following a prior Refusal-to-File and Type A meeting, the FDA's CBER will proceed to review BLA for mRNA-1010.

Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49 ...

Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its investigational seasonal influenza vaccine, mRNA-1010, following a Type A ...

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

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...

In a statement, PTC's chief executive, Matthew Klein, said the company had decided to pull the filing for Translarna (ataluren) as a treatment for nonsense mutation DMD after the FDA said it was ...