Despite efforts to spare employees by scaling back R&D and reducing operating costs by roughly $1.5 billion over the next two ...

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

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

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

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

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.

Novavax’s shot, Nuvaxovid, is the only protein-based COVID vaccine available in the U.S., while Moderna’s mNexspike is a lower-dose, updated version of its original mRNA-based vaccine.

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad ...