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

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

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

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

Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill© mads claus rasmussen/Agence France-Presse/Getty Images The FDA’s deadline to decide on the application will be in the fourth ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response ...

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...

After promising results from separate Phase 2 and 3 trials, Cidara Therapeutics has submitted a new drug application to the US Food and Drug Administration (FDA) for the compound rezafungin, for ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...