US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
Ousted Vaccine Official Says Kennedy Sought Data to Justify Anti-Science Stance, WSJ Reports
(Reuters) -Peter Marks, the FDA's top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary's team ...
'Decapitated': More top vaccine regulators out at FDA, threatening new approvals
More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to ...
FDA delay on Novavax vaccine approval could be bellwether for vaccine sector: BofAS
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
Fierce Pharma1d
Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
BioPharma Dive1d
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
Fierce Pharma6h
GSK, Pfizer resolve RSV patent feud amid vaccine market uncertainty
As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory ...
Novavax bid for full approval of COVID vaccine stymied by FDA - report
The FDA delays full approval for Novavax's COVID-19 vaccine, citing the need for additional data. Read more here.
Targeted Oncology2d
FDA Oncology Actions: March 2025 Approvals and Designations
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...