Food and Drug Administration (FDA)
NEWS
Robert Califf became the new commissioner of the U.S. Food & Drug Administration and emphasized the use of real-world evidence (RWE) in Agency decisions.
Although at-home testing for COVID-19 has been dismal, the revolution in at-home testing has inspired personal tests for several other illnesses.
The FDA has not yet issued any hold orders to Cassava, but the company expects that its time is coming after rivals Denali and Cortexyme received theirs.
First Moscow State Medical University has paused recruiting new patients for its ongoing clinical trials following a disruption in the university’s ability to receive clinical trial samples.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.
Pfizer’s Clostridioides difficile infection vaccine failed to hit the mark, BMS announced priority review for Opdivo in resectable Non-Small Cell Lung Cancer, and Saol enlists help from GeneDx.
Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
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