Food and Drug Administration (FDA)
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With no permanent commissioner, the U.S. Food and Drug Administration appears to be both cracking down on Accelerated Approvals while struggling with a backlog of inspections.
The U.S. FDA approved Gilead and Kite’s Yescarta (axicabtagene ciloleucel) for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The U.S. FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
STI-2099 is a formulation of its antibody against COVID-19 that can be taken in a nasal spray. It is also evaluating the antibody in an intravenous form (STI-2020) in a Phase I trial.
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.
Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration could grant Emergency Use Authorization for its COVID-19 vaccine by May.
The company notes that this decision has no effect on other indications for Keytruda.
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