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The regulatory body has unveiled a list of off-patent and off-exclusivity branded drugs without approved generics, as well as launched a new policy to speed up the assessment

Mitoconix Bio is pioneering a novel strategy to improve mitochondrial function as a disease-modifying therapeutic for treating neurodegenerative disorders, including Huntington's, Parkinson's and Alzheimer's diseases. Proceeds from the

The new campus will be owned by Pfizer and will bring together more than 450 employees who currently work at multiple locations which the company leases in the

Developed by Novartis’ unit Sandoz, Erelzi has been approved as an alternative option for all indications of the reference drug. Erelzi can be used by physicians to treat rheumatoid

The approval has been granted for Kevzara to treat moderately to severely active RA in adult patients who have responded inadequately or who are intolerant to one or

“The hope that Lenti-D may benefit boys facing such a devastating disease inspires all of us at bluebird,” said David Davidson, M.D., chief medical officer, bluebird bio. “Having

In accordance with the FDA's standard review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of February 12,

The company has reported positive data from the primary analysis of the phase III Haven 1 study in adults and adolescents and interim analysis of the phase III

Imraldi has been recommended to be approved for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease,