Tag Archives: approval.

Approval of at-home tests releases a pandemic-fighting weapon

The Food and Drug Administration (FDA) approved inexpensive, at-home coronavirus tests for over-the-counter sales this week, adding a potentially powerful weapon to the nation’s pandemic-fighting arsenal that experts say will likely still be needed despite increasing numbers of vaccinated Americans. One of them is Michael Mina, assistant professor of epidemiology, who has called on federal… Read More »

Moderna stands to earn $300M for quick vaccine approval, up to $6.6B for extra doses: filing

Moderna’s coronavirus vaccine deal with the U.S., announced last week with a $ 1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot’s arrival. The company stands to gain up to a whopping $ 8.125 billion, according to a Moderna… Read More »

Apervita’s NCQA approval helps health plans speed VBC analysis

Value-based care platform provider Apervita says it is the first company to be certified by the National Committee for Quality Assurance for electronic clinical quality measures using a clinical quality language-based engine. The company’s newly certified CQL-based engine—based on HL7 logic standards that support both eCQMs and clinical decision support—can be adopted by healthcare organizations… Read More »

Novo’s Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?

After racing out to a fast start in its first year on the market, Novo Nordisk’s GLP-1 diabetes superstar Ozempic is already proving a darling for the Danish drugmaker. Now, a heart-helping FDA approval will likely spell even more success for the standout––and bodes well for Novo’s other much-touted diabetes launch. The FDA approved Ozempic to reduce the… Read More »