Sarepta Therapeutics, Inc.
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Latest From Sarepta Therapeutics, Inc.
Coronavirus Notebook: UK Rolls Out Ronapreve To Hospitalized Patients, Drug Safety Unit Reviews mRNA Vaccine Heart Inflammation Link
Pressure is growing on richer countries to share their excess vaccine doses, and the European Parliament has passed legislation intended to strengthen the EU’s health security framework and make joint vaccine procurement more transparent.
The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.
Portico with the FlexNav delivery system earned FDA approval for people with symptomatic, severe aortic stenosis who would be at high or extreme risk in open-heart surgery.
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