Sarepta Therapeutics announced Thursday that the U.S. Food and Drug Administration has put the Phase II trial of its Duchenne muscular dystrophy (DMD) candidate SRP-5051 (vesleteplirsen) on clinical hold following a serious safety signal.
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The U.S. Food and Drug Administration released new draft guidance that addresses Breakthrough Therapy designation.
The U.S. Supreme Court on Friday took the dramatic step of overturning the landmark 1973 Roe v. Wade ruling that recognized a woman’s constitutional right to an abortion and legalized it nationwide, handing a momentous victory to Republicans and religious conservatives who want to limit or ban the procedure.
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm (aducanumab-avwa) following its post on ClinicalTrials.gov.
The U.S. Centers for Disease Control and Prevention said on Friday it had recommended Moderna’s COVID-19 vaccine for children and adolescents aged 6 to 17, allowing a rollout of the shots to begin for that age group.
Eton Pharmaceuticals, Inc has sold its hospital products to Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. for total payments of up to $50 million.
Roche was an early ADC pioneer with the approved drugs Kadcyla and Polivy but failed to make further headway.
COVID-19 vaccines this fall are likely to be based on the Omicron variant of the coronavirus rather than the original strain, although some experts suggest they may only offer significant benefits for older and immunocompromised people.
Late-stage data on an experimental COVID-19 vaccine from Sanofi and GSK has showed the shot confers protection against the Omicron variant of the virus, the companies said. The so-called bivalent vaccine targets the Beta variant – first identified in South Africa – as well as the original Wuhan strain of the virus.
Advisers to the U.S. Centers for Disease Control and Prevention (CDC) are meeting on Thursday to decide on the use of Moderna Inc.’s COVID-19 vaccine for children and adolescents aged 6 to 17, after months of delay in that age group due to safety concerns.