In a study published today in The New England Journal of Medicine, Greinacher and his colleagues show that the first theory ...

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, ...

Regulators move the goalposts for a manufacturer that uses mRNA technology.

America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for ...

So: Moderna says it was blindsided by the FDA, and Vinay Prasad, on its mRNA flu vaccine. Meanwhile, regulators are moving ...

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.

Shares of Moderna slumped nearly 9% in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to ...

In a winter marked by flu outbreaks, the persistence of Covid-19, and surges of measles cases across the United States, an ...

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...

After inaugurating the fourth meeting of the Organisation of Islamic Cooperation (OIC) Vaccine Manufacturers Group (VMG) at ...

Former Scottish health secretary Jeane Freeman has died at the age of 72 from cancer, her family said in a statement. The SNP ...