The FDA enlisted British drugmaker GSK to help it fast-track approval of leucovorin to treat an autism-related disorder.

The cryoablation treatment is indicated for women aged 70 and above with early-stage, low-risk breast tumours.

The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, ...

U.S. Health Secretary Robert F Kennedy Jr. could deliver a policy win for the Trump administration in just a few months after ...

This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.

The US Food and Drug Administration (FDA) recently granted approval to Evita Solutions for its generic version of mifepristone, a medication used to end early pregnancies up to 10 weeks.

Supply chain disruptions with biosimilars will threaten the entire biologics ecosystem, writes a Samsung Bioepis VP and head ...

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting ...

IceCure Medical ICCM recently received FDA marketing authorization for its ProSense cryoablation system, marking the first ...

The body's tissues can get injured in many ways, but while some injuries heal perfectly, others don't heal at all. A cut in the skin, for example, usually heals all on its own, while internal organs, ...

Echo IQ has not been rewarded a crucial US reimbursement code, but hopes a new category for innovative AI plays will save the ...

Surgical robotics is not a new phenomenon, but it's a space that continues to foster innovation across a range of ...