Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...

Writing in JAMA, four former governmental officials warn that the Trump administration’s involvement in delaying the approval ...

RFK Jr.'s newly appointed CDC panel, half of whom oppose vaccines, prepares to review key data on COVID, RSV, and flu shots.

The Centers for Disease Control and Prevention's vaccine advisory committee is set to meet for the first time since Health ...

Shares of San Diego-based Cidara Therapeutics Inc. (NASDAQ:CDTX) were trading at $40.41, up $19.39, or 92%, on positive top-line results from its randomized, double-blind, placebo-controlled phase IIb ...

The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just ...

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...

Novavax, Inc. faces profitability challenges despite a promising tech platform, with uncertain revenue streams. Click for my ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

The FDA has approved Nuvaxovid to prevent COVID-19 in adults 65 years and older and high-risk individuals 12 through 64 years.

Novavax NVAX announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.