News

FDA’s Makary: Covid shot guidance coming soon
FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...
STAT2h
FDA chief pushes back on senators’ criticism, says Covid booster trials should take ‘roughly a year’
The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of ...
STAT1hOpinion
The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...
STAT1d
FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say
The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...
MedPage Today on MSN1d
FDA Officials Detail Plan to Limit COVID Shots
The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...
New FDA chiefs limit Covid-19 shots to elderly, sick
FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...
Fierce Pharma2d
FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach
The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...
FDA chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.
BioSpace1d
FDA’s New Risk-Based Approach to COVID-19 Vaccines Aims to Ease ‘Public Distrust’: Makary, Prasad
The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...
Marty Makary
Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an ...
BioSpace3d
FDA Grants Narrow Approval of Novavax’s COVID Shot as Makary Teases Changes to Vaccine Approval Framework
The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that ...