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 ...

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.

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

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 ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June ... “I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine ...

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.

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 ...

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML. A New Drug Application (NDA) has been submitted to the Food and Drug Administration ...

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 ...