FDA Commissioner Marty Makary was met with a skeptical set of Senate appropriators Thursday when he testified on his agency’s ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud.

The question was asked by Capt. Sarah Meyer, a pediatric vaccine expert with the Centers for Disease Control and Prevention and member of the committee, the Vaccines and Related Biological Products ...

Samsung Biologics Co., the world’s largest contract drugmaker, will undergo a strategic split to separate its contract development and manufacturing orga ...

While gaps persist in workforce retention, infrastructure, and equitable access, the transformation of Nigeria’s health ...

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...

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

Pfizer faces several headwinds, including patent cliffs, regulatory risks, and a setback in obesity drug development. Click ...