Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...

Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) ...

We never sold the combination in the countries where it's banned. Our exports were done only after getting valid product permissions from the State FDA and required export NOCs,' said Arvind Sharma, ...

This is also Sun Pharma's second acquisition in less than three months and comes as the company looks to size up its specialty therapy portfolio.

Q4 2024 Earnings Call Transcript March 7, 2025 Operator: Good morning, and welcome to the Molecular Partners Fourth Quarter ...

The logo of Danish drugmaker Novo Nordisk in their offices in Hillerod, Denmark, September 26, 2023. REUTERS/Tom Little/File Photo Novo Nordisk on Monday revealed weaker-than-expected data from a ...

Bioventus' full-year 2024 worldwide revenue totaled $573.3 million, an increase of 11.9% compared to the prior year. On an organic* basis, revenue increased 14.4%, driven by double-digit growth in ...

Full Year 2024 results in line with guidance with Commercial Channel revenue up 17% Strong International OA Pain Management and greater th ...

Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and ...

FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...

“I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to ...