FDA
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
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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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The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
The panel opposed approval of Daiichi Sankyo’s AML drug but supported approval for its TGCT treatment.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
Neuronascent Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for its proprietary oral therapeutic, NNI-362, to proceed into Phase 1 clinical testing in a healthy aged population.
On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.