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

Writing in separate editorials in The New England Journal of Medicine and The Journal of the American Medical Association, ...

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

The regulator is still investigating “additional adverse event cases," a spokesperson told Endpoints News on Wednesday.

Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA ...

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

Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief Clinical Officer Lynn Kramer expressed unwavering conviction in his ...

Job listings in the area have ticked up in the last month. These seven companies are hiring in South San Francisco right now, ...

For the second month in a row, job postings on BioSpace increased in key biopharma disciplines. However, application rates ...

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at ...

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

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