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Sarepta Therapeutics shared positive topline results from its ongoing SRP-9001-102 study on the effectiveness of delandistrogene moxeparvovec in treating Duchenne muscular dystrophy.
BioSpace picked the brains of 10 biotech CEOs and founders, to solicit their advice for first-time founders.
The company has produced a varied pipeline focused on the development of precision pharmacological treatments for nine different programs.
Another drug Vounatsos heralded was zuranolone, which Biogen is developing with Sage Therapeutics for multiple forms of depression.
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.
Moderna roared through 2021 on the strength of its COVID-19 vaccine and that momentum is continuing in 2022.
Sigyn is not only trying to treat the inflammatory mediators that fuel sepsis; it wants to prevent the life-threatening event from occurring altogether.
BMS and Century Therapeutics agreed to collaborate on the research, development, and commercialization of up to four T cell programs for hematologic malignancies and solid tumors.
The collaboration covers several neurodevelopmental targets, including Rett syndrome, SYNGAP1 syndrome, and one other disease yet to be disclosed.
FDA
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.
FDA
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
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