Eton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and ...

SHELTON, CT / ACCESS Newswire / June 4, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company ...

XP 8121 is a combination drug meant to better control hypothyroidism, in part by moving its common therapy, levothyroxine, ...

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene ...

Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about ...

Kura Oncology and Kyowa Kirin submitted data from the KOMET-001 trial, which the agency will review and decide whether to approve the drug by Nov. 30.

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed ...

and a new drug application (NDA) had not yet been issued. Unfortunately, since that time the 'treatment IND' option has been eliminated and the compassionate use of drugs is rarely, if ever ...

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

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as well as clinical testing conducted under an Investigational New Drug application – such as testing in healthy human volunteers, dosing and pharmacokinetic studies, and final safety and ...

A new once-daily pill may raise the bar for weight loss meds. Ozempic, Mounjaro and similar drugs that mimic the GLP-1 hormone the body naturally produces after eating can cause significant weight ...