The attention-getting articles about COVID-19 included news about Pfizer's booster and the FDA's rejection Zyesami (aviptadil) for treatment of COVID-19-related respiratory failure.
The FDA didn’t have enough data to assess the risks and benefits of Zyesami.
Regeneron also announced an expanded contract with the U.S. government for the purchase of additional doses of REGEN-COV.
The FDA had previously issued an EUA for those over the age of 65 and those at high risk for severe COVID-19 or exposure to the virus.
Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.
The dose is one-third of the dose given to people 12 years and older.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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