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The antiviral was first approved in 2018 for treating uncomplicated flu in patients 12 and older who have been symptomatic for no longer than 48 hours. Read More
UK regulators are reviewing the latest data on the Pfizer/BioNTech COVID-19 vaccine candidate and aim to decide on an approval “in the shortest time possible, without compromising the thoroughness of our review,” the agency’s top official said yesterday. Read More
Regeneron has won Emergency Use Authorization (EUA) from the FDA for its investigational antibody cocktail for the treatment of patients with mild-to-moderate COVID-19 symptoms at high risk of severe disease progression or hospitalization — and an initial 30,000 doses are expected to ship today. Read More
Pfizer has released promising results from a global phase 3 trial of its non-small cell lung cancer (NSCLC) investigational treatment, Lorbrena (lorlatinib). Read More
The FDA has granted an Emergency Use Authorization (EUA) for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) for treatment of COVID-19 patients needing supplemental oxygen. Read More
The study involved 4,566 men who have sex with men and spanned research sites in the U.S., Argentina, Brazil, Peru, South Africa, Thailand and Vietnam. Read More
The drug previously received Orphan Status from the FDA and the European Medicines Agency for other muscular degenerative diseases, including a form of muscular dystrophy. Read More