Novartis’ bid to pump up sales of Entresto beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended the heart failure medicine be used to treat a different form of the disease.
The U.S. Food and Drug Administration authorized emergency use of the first over-the-counter Covid-19 antigen test, which can be used at home.
Moderna Inc.’s Covid-19 vaccine appeared set for regulatory authorization after U.S. Food and Drug Administration staff endorsed it as safe and effective in released documents.
The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.
A U.S. Centers for Disease Control and Prevention advisory panel on Dec. 12 recommended the nation’s first COVID-19 vaccine, helping clear the way for public health authorities to begin the largest vaccination campaign in U.S. history.
Top U.S. Food and Drug Administration regulators said most Americans with allergies should be safe to receive the Covid-19 vaccine developed by Pfizer Inc. and Germany’s Biotech SE.
The United States hit a record 16 million Covid-19 cases on Dec. 12, with deaths closing in on the 300,000 mark, as millions of doses of a new vaccine were expected to start rolling out across the nation on Dec. 13.
The United States authorized the use of Pfizer Inc’s Covid-19 vaccine on Dec. 11, with the first inoculations expected within days, marking a turning point in a country where the pandemic has killed more than 295,000 people.
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration authorized the emergency use of the mRNA vaccine, BNT162b2, against Covid-19 in individuals 16 years of age or older.
The chief executive of Germany’s BioNTech SE said the biggest challenge facing the company and partner Pfizer Inc. now that their Covid-19 vaccine is authorized for use in the United States will be to scale up manufacturing to meet huge demand.
