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This designation comes after the FDA Office of Orphan Products Development reviewed recent Phase IIa clinical trial results, which showed both biological efficacy and safety in patients with

The FDA’s designation is designed to expedite the review of treatments. It offers opportunities for more frequent discussions with the FDA regarding the clinical development plan of a

This move is a significant step in the company’s global expansion strategy, focusing on enhancing the availability of essential cancer therapies. Bevacizumab is a targeted therapy designed to

This new facility is part of Southern Research’s ongoing work in human health and biomedical threat research. The $98m facility located at corner of Richard Arrington Jr. Boulevard

Iron deficiency anaemia (IDA) is a common complication in chronic kidney disease, and is linked with increased cardiovascular risks and mortality. Viatris’ Iron Sucrose Injection is an intravenous

Vonaprument, formerly known as ANX007, is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation. It has secured Priority

This acquisition expands Intas and Accord’s biosimilar portfolio approved by the FDA and expedites their growth in the global market. With the acquisition, Intas’ US speciality business Accord

CTx-1301 is an extended-release tablet formulation designed for fast onset, all-day efficacy, and a smooth pharmacokinetic profile with a single dose. Cingulate anticipates learning whether the NDA has

The approved drug is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults aged 18 years and above, as well as children between six to