FDA
All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
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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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In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs that received it.
HIV patients have some good news this morning. The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Symtuza, the first and only complete darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1).
Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.
Shares of Siga Technologies soared more than 11 percent late Friday after the company announced that its smallpox treatment Tpoxx was approved by the U.S. Food and Drug Administration.
July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month there are only four more approvals on the docket, here are the remaining approvals scheduled for July.
The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.
On May 29, the FDA cleared T2 Biosystems’ T2Bacteria Panel for diagnosis of sepsis. In that sepsis is the third-leading cause of death in the U.S., this emphasizes the importance of work in this area.
Has the U.S. Food and Drug Administration failed to do its due diligence in finding and reporting financial conflicts of interest between members of its scientific advisory committees and pharmaceutical companies?