FDA Commissioner Marty Makary and Dr. Vinay Prasad outlined their booster shot clinical trial requirements in the New England Journal of Medicine.

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may ...

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

In an era that FDA Commissioner Marty Makary, MD, MPH, calls an "epidemic of distrust" toward health institutions, previously ...

During an interview in late April with Dr. Phil, Robert F. Kennedy Jr. reiterated his appeal to parents on vaccine safety: ...