One of the most significant biomedical achievements of the 21st century, mRNA vaccines have reshaped the world’s ability to ...

H-D Feminine Health, announces it has initiated the first randomized, placebo-controlled, double-blinded Phase 3 clinical trial cleared to proceed by the U.S. Food and Drug Administration (FDA) to ...

The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

The U.S. Food and Drug Administration has approved Insmed's oral drug for a type of lung disease, the company said on Tuesday ...

Travere Therapeutics restructures to boost financial health, expands the kidney therapy pipeline, and sees rapid growth for ...

The FDA accepted vepdegestrant’s new drug application for ER+/HER2–, ESR1-mutated advanced breast cancer with a June 5, 2026, ...

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

The NDA for the gonorrhea indication is supported by data from the EAGLE-1 study, which compared the safety and efficacy of oral gepotidacin to a standard of care combination.

Patients on a combination of toripalimab and RemeGen's anti-HER2 antibody disitamab vedotin fared better than those on a chemotherapy regimen.

Shares of Tiziana Life Sciences gained after the biotechnology company said the Food & Drug Administration approved the investigational new drug application for a trial of its treatment for multiple ...

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.