Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

This risky biotech company faces significant challenges ahead. But it has already proven its worth and may be able to do so ...

Sound more like science fiction than actual science? Then, brace yourself because there are, at least, 15 breast cancer vaccine clinical trials in various stages in the U.S., some in phase II and III.

MRNA's second-quarter results are likely to spotlight a sharp decline in Spikevax sales, RSV uptake and key pipeline ...

Corporate Counsel, in partnership with ALM Intelligence, on Monday released its 2025 General Counsel Report, an exclusive ...

US Health Secretary Robert F. Kennedy Jr.’s vaccine policies and commentary largely appear to contradict his pledge to revamp ...

The latest health updates include Centene's improved profitability forecast, US-initiated healthcare data-sharing plans ...

Today in History for July 27: In 1606, the first permanent French colony in Canada was established at Port Royal, N.S.

If you're confident that its current trials will prove successful, then this is one to buy and sit on. One word of caution ...

The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.