Shares of Lupin are set to be in focus after it received US FDA approval for its generic Loteprednol Etabonate Ophthalmic Gel ...

With an FDA IND clearance, the firm will test IKS014 as an alternative for HER2-positive solid tumor patients in the US who have relapsed on other therapies.

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

Managed Healthcare Executive gives C-suite executives in health plans and provider organizations news and strategies for value-driven solutions.

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), ...

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

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

Pounding away on a prison typewriter, Chad Scott seemed worlds apart from President Donald Trump. But when the disgraced ...

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 ...