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

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

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.

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

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

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

Novo Nordisk NOVO.B-2.41%decrease; red down pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a ...

Unicycive Therapeutics, Inc. has announced that the FDA is reviewing its New Drug Application for oxylanthanum carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease ...

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed ...

Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the ...

Aldeyra plans to resubmit the new drug application with new trial data later this year. Perspective from Darrell E. White, MD The FDA issued a complete response letter for the resubmission of the ...

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 ...