On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support ...

Drug developers secured approvals for 46 new therapeutic agents from the FDA’s Center for Drug Evaluation and Research (CDER) in 2025. This cohort brings the 5-year average down a touch, to 48 new ...

If you’ve ever looked at your blood pressure numbers and wondered, “What does that actually mean?”, you’re not alone. High blood pressure affects millions of Americans, and many don’t even realize ...

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across all age ranges. “FDA is doing a thorough investigation, across multiple age ...

A dozen prior leaders of the Food and Drug Administration — appointed by Republicans and Democrats alike — issued a scathing denunciation of new FDA assertions casting doubt on vaccine safety. The ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people's food. Consumers should check ...

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs. “FDA announced over 40 job announcements for ...

The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug. The probe comes as the regulator says it ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...