US FDA Approval Activity Could Cool Down In September
With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.
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Decision on Regeneron’s Ebola virus therapy, which uses a similar monoclonal antibody cocktail approach as the company’s COVID-19 therapy candidate, stands out among the 10 user fee goal dates in the coming month.
Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.