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Within hours of the FDA authorizing booster doses of the Pfizer and Moderna COVID-19 vaccines for all adults, a Centers for Disease Control and Prevention (CDC) expert panel unanimously supported the decision. Read More
If approved, Paxlovid would be the first oral antiviral of its kind that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection. Read More
Biogen’s Aduhelm (aducanumab) appears unlikely to receive a marketing authorization in the EU, after a European Medicines Agency expert panel issued a “negative trend” vote on the antiamyloid antibody. Read More
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