Spruce Biosciences is cutting over half of its employees as it looks to secure accelerated approval of a Sanfilippo syndrome ...

The FDA is currently reviewing Merck’s sBLA for Keytruda in head and neck cancer, with a target action date of June 23.

Pfizer’s sasanlimab, when used with standard of care, reduced the likelihood of disease recurrence or progression, death due ...

The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of ...

With the American Association for Cancer Research’s annual conference now underway, oncology researchers can expect ...

With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the ...

As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene ...

DELFI Diagnostics has clinically validated FirstLook Lung, its blood test designed to improve early detection of lung cancer, ...

While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics business, plus the same macro headwinds blowing against the entire industry.

As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering ...

In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, ...

The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent ...