Peter Marks, the FDA’s top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary’s team sought ...

As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, ...

The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...

Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...

Biotech stocks face a tough 2025 with SMid-cap losses up to 40% YTD. BofA cites FDA changes, tariffs, and capital struggles but notes potential opportunities.

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request more data beyond the April 1 deadline.

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries ...

In an unusual move, top Trump FDA official Sara Brenner, MD, MPH, directly intervened in an agency review of Novavax's ...

The Food and Drug Administration had already indicated that it approved the vaccine, but new agency leaders are now requesting more data. Meanwhile, FDA staffers who oversaw expert panel meetings on ...

The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1.

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...