Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief ...

Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies ...

Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 ...

Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug ...

Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings ...

The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies ...

The ACIP decided 6–3 to postpone its vote on hepatitis B vaccination changes after the language of the questions was ...

Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing ...

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s ...

Tracy Beth Høeg—a known vaccine skeptic—will lead the FDA’s Center for Drug Evaluation and Research as acting chief, becoming ...

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...

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