The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet ...

With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, ...

Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” ...

Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the ...

For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating ...

Analysts had noted "unease" from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a "significant ...

Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.

Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.

Venture capital flow to women-founded companies has stabilized in the post-pandemic environment. BioSpace looks back at five companies that have nabbed the most over the past two decades.

Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the ...

This week's meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor ...

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug ...