The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla.

A fter just a few controversial months, Vinay Prasad, MD, MPH, has stepped down as director of FDA's Center for Biologics Evaluation and Research (CBER).

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

The mNEXSPIKE approval marks Moderna’s third FDA-approved product, giving them a heftier commercial portfolio than many investors give them credit for.

Dupixent (dupilumab) Interleukin-4 receptor alpha antagonist Treatment of adult patients with bullous pemphigoid. Dupixent Gains Approval for Bullous Pemphigoid mNexspike (COVID-19 vaccine ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

The new vaccine (mNexspike [COVID-19 Vaccine, mRNA]) represents a significant step forward in the development of next-generation coronavirus vaccines, the Associated Press reported.

Moderna MRNA announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will be marketed under ...

Moderna’s new COVID-19 vaccine, named mNexspike, is a fifth of the dose of its current COVID-19 vaccine, Spikevax. It is considered a step toward next-generation coronavirus vaccines.