The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

A novel oral peptide PN-477o with once-daily dosing, high potency and activation of glucagon-like peptide-1 (GLP-1), ...

During June, investigators reported new data that has advanced the treatment landscape for lung cancer, including new FDA ...

FDA issues a complete response letter for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients with chronic ...

Nicox completed the Denali Phase 3 trial for NCX 470, targeting open-angle glaucoma and ocular hypertension. NCX 470 combines ...

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.

President Trump's unconventional approach to clemency has spread hope among federal prisoners and formerly incarcerated people around the United States.

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...