Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the EU approval of mNexspike ...

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines ...

The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

Moderna Inc. fell Monday after the Food and Drug Administration said in a memo late last week it would place new restrictions on which vaccines hit the market. Vinay Prasad, a top FDA official, blamed ...

NEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

A Food and Drug Administration (FDA) memo has reported that the COVID-19 vaccine contributed to the deaths of at least 10 children. Following the release of the Friday memo, which was obtained by ...

The federal agency has not publicized how it reached its conclusions. The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval ...

Bill McColl has 25+ years of experience as a senior producer and writer for TV, radio, and digital media leading teams of anchors, reporters, and editors in creating news broadcasts, covering some of ...

The Food and Drug Administration intends to get tougher on vaccine approvals, as top officials raised concerns about the risk of COVID vaccines for children. Speaking on Fox News Saturday morning, FDA ...

The Utah plastic surgeon faced up to 35 years in prison if the jury found him guilty on charges that included conspiracy to ...