FDA Refuses to Review Moderna’s New Flu Shot

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...
Mayo Clinic on MSN

COVID-19 vaccines: Get the facts

Find out about the COVID-19 vaccines, the benefits of COVID-19 vaccination and the possible side effects.

FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its ...
STAT

FDA’s rejection of Moderna threatens to stifle broader vaccine industry

Experts say the FDA "moved the goalposts" on Moderna, creating "a destructive precedent that will undermine the future of ...
STAT

Moderna’s president weighs in on FDA’s decision not to review its flu vaccine

In an interview, Moderna President Stephen Hoge took questions on an FDA decision on the biotech's mRNA flu vaccine, as well ...

Clinical Trials Show Moderna's New mRNA Flu Vaccine Is Safe and Effective. FDA Won't Even Consider It.

This week, vaccine manufacturer Moderna revealed that Vinaya Prasad, the top vaccine regulator at the Food and Drug ...

Doctor concerned FDA refusal to review mRNA flu vaccine will affect other research

Moderna said it’s requesting a meeting with the U.S. Food and Drug Administration after receiving a “refusal-to-file” letter, ...

Moderna Expected to Post Lower 4Q Sales as Vaccine Regulatory Path Looks Uncertain -- Earnings Preview

PROFIT: The pharmaceutical company is expected to report a loss of $1.02 billion, or $2.54 a share, according to analysts polled by FactSet. That compares with a loss of $1.12 billion, or $2.91 a ...