Khindivi is the sole FDA-approved hydrocortisone oral solution and is available in a 1mg/ml concentration. This formulation ...

ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution. The Food and Drug Administration (FDA) has accepted for review ...

SHELTON, CT / ACCESS Newswire / May 22, 2025 / Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE Amer.:NNVC ) (the ...

The Food and Drug Administration has rejected an application filed by Langhorne-based Savara for its new drug candidate ...

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

Rutgers Health researchers have developed an oral antiviral drug candidate for COVID-19 that could overcome major limitations of Paxlovid, currently the most prescribed oral treatment. As with its ...

Novo Nordisk NOVO.B-0.75%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 ...

Merck and Japan-based Daiichi Sankyo have withdrawn their U.S. application for an experimental lung cancer treatment after it ...

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 ...

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 ...

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 ...