Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the regulatory agency authorize Novavax Inc.’s COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.
Tag Archive for: U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration approved the use of Sanofi and Regeneron Pharmaceuticals Inc.’s anti-inflammation drug Dupixent to treat eczema in young children, the two companies said on Tuesday.
Bayer is building an oncology powerhouse. The Germany-based biopharma leader is on a mission to become one of the top 10 oncology companies by 2030, and an ambitious mission requires an equally driven leadership team. To that end, Bayer snagged ex-GSK global oncology head Christine Roth to lead the company’s Oncology Strategic Business Unit, then dipped into GSK waters again to bring Tara Frenkl on board as head of oncology development.
Bluebird bio’s blood disorder treatment demonstrates “clinically meaningful” benefit in patients, staff reviewers at the U.S. Food and Drug Administration said in briefing documents published on Tuesday.
Abbott Laboratories said on Saturday that the company has reopened its baby formula production plant in Sturgis, Michigan, taking a step toward alleviating an acute nationwide shortage that has sent parents scrambling for supplies.
U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc.’s vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.
A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.
Pfizer Inc. and partner BioNTech completed the filing with the U.S. drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.
Servier today announced that the U.S. Food and Drug Administration approved TIBSOVO (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
