German biotech firm CureVac enrolled the first participant for a Phase 2b/3 clinical trial of the company’s Covid-19 vaccine candidate.
The U.S. Food and Drug Administration approved BioCryst Pharmaceuticals Inc.’s Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and young patients 12 years and older.
The U.S. Food and Drug Administration approved Genentech and Blueprint Medicines’ Gavreto (pralsetinib) as a treatment for adults and pediatric patients 12 and older who have been diagnosed with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).
The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
The U.S. government will start distributing Regeneron Pharmaceuticals Inc.’s newly authorized Covid-19 antibody combination on Nov. 24, beginning with more than 30,000 treatment courses, a health official said.
The U.S. Food and Drug Administration issued emergency use authorization for Regeneron Pharmaceuticals Inc.’s Covid-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.
U.S. hospitals, weighing high demand and tight supplies, said they may limit use of the new Eli Lilly and Co. nantibody drug bamlanivimab to Covid-19 patients with multiple risk factors for serious illness or to those whose immune systems have not begun to fight the infection.
There are some questions about how effective Eli Lilly’s antibody neutralizing antibody bamlanivimab (LY-CoV555) will prove to be in the battle against Covid-19 due to labeling limitations.
A combination of Canadian drug developer Medicago’s experimental Covid-19 vaccine and a booster from Britain’s GlaxoSmithKline will enter a large study with more than 30,000 volunteers in 2020.
U.S. regulators authorized emergency use of the first experimental antibody drug for Covid-19 in patients who are not hospitalized but are at risk of serious illness because of their age or other conditions.