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Pfizer has filed its application with the FDA for Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, Paxlovid, for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalization or death. Read More
The European regulator noted the positive opinions for the COVID-19 treatments mark the first such recommendations for monoclonal antibodies. Read More
The European Medicines Agency (EMA) has given the thumbs up to two COVID-19 antibody therapies from Regeneron-Roche and Celltrion Healthcare, paving the way for imminent approval by the European Commission. Read More
The new formulation is a big win for patients who currently rely on the liquid form administered through nebulization, said Damian deGoa, the company’s CEO. Read More
Pfizer and BioNTech are seeking an amended Emergency Use Authorization (EUA) from the FDA allowing their COVID-19 vaccine booster for general use in adults over age 18. Read More
Liquidia has grabbed tentative FDA approval for Yutrepia, the first inhalation powder form of treprostinil, a vasodilator used in other forms to treat pulmonary hypertension. Read More
Indonesia, which has a population of more than 273 million, has already granted emergency use approval to the vaccine, to be manufactured by the Serum Institute of India. Read More
Merck’s and Ridgeback Biotherapeutics’ oral COVID-19 medication got its first green light from a regulatory body this week when the UK approved it, making it the first oral antiviral medicine authorized for the treatment of COVID-19. The companies still await authorization from the FDA, which could come early next month. Read More
The approvals were supported by positive phase 1 and phase 3 data in which Scemblix (asciminib) showed superiority in patients’ major molecular response rate when compared against Pfizer’s Bosulif (bosutinib). Read More