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

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

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

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

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

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

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

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

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

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

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

While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, ...