The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
Gov. Greg Gianforte is accepting applications and nominations to fill a district court vacancies in the Sixth Judicial ...
New Jersey residents can now apply for property tax relief programs using the PAS-1 form, which combines Senior Freeze, ...
EdgeMode (OTC: EDGM), a global Energy and AI data center infrastructure company, today announced continued progress in the review of its Form 211 submission made by its sponsoring market maker to ...
A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
The Staff statement provides a technology-neutral framework for understanding securities tokenization models and emphasizes the consistent ...
Six binders totaling more than 3,000 pages. That, in physical form, is the NextEra Energy Transmission MidAtlantic ...
The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...
Spouses qualify for burial with the veteran even if the spouse remarried after the veteran's death. That detail surprises ...
Here’s everything you need to know about applying for a business master’s—including selecting a program, refining your resume, and preparing for interviews ...
Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence ...
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