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 ...
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 ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
In its new update, Moderna said that it had held a meeting with the FDA's Center for Biologics Evaluation and Research (CBER) and agreed on a "revised regulatory approach" that has allowed the review ...
Following a prior Refusal-to-File and Type A meeting, the FDA's CBER will proceed to review BLA for mRNA-1010.
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its ...
US mRNA specialist Moderna today announced that, in response to a prior Refusal-to-File (RTF) letter, the company engaged ...
Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...
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 ...
Savara (NASDAQ:SVRA) executives provided an update on the company’s regulatory timeline, manufacturing changes, clinical ...
The PDUFA date for mRNA-1010 in seasonal influenza is set for 5 August 2026, meaning the vaccine could be on the market for ...
For drugmakers and vaccine developers, an FDA reversal on Moderna's flu vaccine is better than the alternative. But it is also another sign of agency chaos.
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