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

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified ...

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 ...

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

Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound ...

Ophthalmology Times - ophthalmology news, articles, and events in a timely and accurate manner for members of the ophthalmic ...

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

Instead, Stealth submitted a new drug application seeking approval of elamipretide, and the FDA issued its refusal-to-file ...

The FDA has accepted for priority review the new drug application for sevabertinib (BAY 2927088) to treat certain patients with NSCLC.

BioCryst has also filed its line extension application for the use of ORLADEYO oral granules in patients with HAE aged 2 to 11 years with the European Medicines Agency. Additional regulatory filings ...

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

Moderna said on Friday it has filed a marketing application for the review of its updated COVID-19 vaccine with the U.S. Food ...