The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The United States is tying payments for Covid-19 vaccines to timing milestones for production and approval, according to public documents and a Trump administration official, putting pressure on drugmakers including Moderna Inc. to meet ambitious targets.
(Reuters) – Any potential COVID-19 vaccine backed by the Trump administration’s “Operation Warp Speed” program is unlikely to receive a green light from regulators any earlier than November or December, given the time needed for a large-scale clinical trial, the National Institutes of Health director said on Thursday. In a call with reporters, Francis Collins […]
The United States entered an agreement with drugmaker Moderna Inc. to acquire 100 million doses of the company’s potential COVID-19 vaccine for around $1.5 billion, the company and White House said.
Omeros Corp.’s experimental treatment helped six patients with acute respiratory distress syndrome caused by Covid-19 recover and get discharged from the hospital, sending the drug developer’s shares up 60%.
GlaxoSmithKline and Sanofi struck a $2.1 billion deal with the U.S. government’s Operation Warp Speed program to supply an initial 100 million doses of a Covid-19 vaccine candidate under development by the two companies.
The National Institutes of Health is investing $248.7 million in seven diagnostic companies with new testing technologies to increase their testing capacities and make millions of rapid Covid-19 tests per week available by fall.
The National Institutes of Health (NIH) announced plans to launch a “flurry” of large-scale clinical trials for treating Covid-19.
Phase I data from the Covid-19 vaccine under development by AstraZeneca and Oxford University’s Jenner Institute is showing a robust defense against the novel coronavirus that has infected more than 13 million people across the globe.
Life sciences company IQVIA Holdings Inc. will collaborate with AstraZeneca Plc to speed up clinical studies of the British drugmaker’s potential COVID-19 vaccine in the United States.