BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its Biologics License Application (BLA) for Roctavian (valoctocogene roxaparvovec), an AAV gene therapy for adults with severe hemophilia A.
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Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.
An experimental vaccine provided broad protection against all 20 known influenza A and B virus subtypes in initial tests in mice and ferrets, potentially opening a pathway to a universal flu shot that might help prevent future pandemics, according to a U.S. study published on Thursday.
Recent uptake of COVID-19 vaccine booster doses in the European Union has been “rather disappointing,” an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter.
There is now an imminent threat of measles spreading in various regions globally, as COVID-19 led to a steady decline in vaccination coverage and weakened surveillance of the disease, the World Health Organization (WHO) and the U.S. public health agency said on Wednesday.
The partnership with non-profit IVI, headquartered in South Korea, aims to boost output and reduce vaccine shortages amid a spate of global outbreaks that spurred the World Health Organization to temporarily change its dosage regime.
Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).
The decision, which could be announced as early as Wednesday comes in response to growing pressure from senior Biden officials, who privately urged WHO leaders to change the name.
Hemgenix is an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.