FDA
The letter was related to a 2021 FDA inspection connected to Sesen’s Biologics License Application for Vicineum. Read more about this sesen bio news here.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 4, 2020.
The U.S. Food and Drug Administration green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus and developed antibodies to the disease.
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 30, 2020.
Zejula, GlaxoSmithKline’s once-daily PARP inhibitor, won regulatory approval as a monotherapy maintenance treatment for women with advanced ovarian cancer whose disease is responsive to first-line platinum-based chemotherapy, regardless of biomarker status.