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Relief Therapeutics and NeuroRx have applied to the FDA for an Emergency Use Authorization (EUA) for RLF-100 (aviptadil) for the treatment of critical COVID-19 patients with respiratory failure. Read More
The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy. Read More
Manufacturers of dexamethasone can request the new indication be added to their product’s licenses by submitting applications to national medicines agencies or the EMA. Read More
Jardiance is currently approved to lower blood sugar in adults with type 2 diabetes and for reducing the risk of cardiovascular death in patients with type 2 diabetes and known cardiovascular disease. Read More
The FDA has hit Mallinckrodt Pharmaceuticals with a second complete response letter (CRL), denying approval of its new drug application (NDA) for terlipressin for the treatment of adults with hepatorenal syndrome type 1(HRS-1) and calling for more data. Read More