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

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

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 ...

New questions about lung cancer in ‘never-smokers’ As the number of people who smoke has gone down over the decades, those who never smoked have begun to make up a greater proportion of lung cancer ...

The U.S. Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

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, ...

Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used ...

Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu vaccine, with the company claiming this decision is inconsistent with ...

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

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

The Food and Drug Administration last week refused to review Moderna’s application for its messenger RNA flu vaccine, in a ...