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The regulatory agency has determined that the NDA is a class 2 review, which leads to a six-month review period from the date of resubmission. It has set

OCA is a farnesoid X receptor (FXR) agonist, which is marketed as Ocaliva by Intercept in the US to treat PBC. Bezafibrate is a pan-peroxisome proliferator-activated receptor (pan-PPAR)

The products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Kimyrsa (oritavancin). Under the terms of the deal, Xediton Pharmaceuticals will handle the registration and commercialisation

Filed in the US Bankruptcy Court for the Southern District of Texas, the proceedings will allow the company to pursue expedited sales process. Athenex will sell its assets

The company will initially buy a 60% interest in Nutrasource while having the right to pick the remaining 40% holding in 2026. Financial terms of the transaction were

The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is

Through the collaboration, Sandoz will gain access to Just – Evotec Biologics’ AI-driven, fully integrated technology platform, which provides development and continuous manufacturing of fully integrated drug substance.

This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance,

The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with