Food and Drug Administration (FDA)
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Gene editing has broken through to a new level as a Maryland man recovers from surgery in which a heart from a genetically modified pig may save his life.
The Centers for Disease Control recommends wearing a mask in health care settings and other places where people around may have risk factors for severe consequences of COVID-19.
Sarepta Therapeutics shared positive topline results from its ongoing SRP-9001-102 study on the effectiveness of delandistrogene moxeparvovec in treating Duchenne muscular dystrophy.
Allogene announced that the chromosomal abnormality was not detected in any manufactured AlloCAR T product or any patient treated with the same lot of drugs.
The collaboration covers several neurodevelopmental targets, including Rett syndrome, SYNGAP1 syndrome, and one other disease yet to be disclosed.
While Biocon intends to address the CRL, the company has not established a timeline for the resubmission of data and hopes that the FDA will rapidly review the BLA when it does submit the data.
The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
The results over the two-year evaluation period for its Phase III GENEr8-1 trial showed consistent clinical benefit from using valoctocogene roxaparvovec.
Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT is of paramount public importance and demands that the FDA make the data publicly available within eight months.
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