📚 Extracted Documents

This is a press release from the U.S. Food and Drug Administration detailing a proposed action to expand the list of active ingredients permitted in sunscreen products, including bemotrizinol. The proposal aims to modernize the regulation of sunscreens and offer consumers more options by adding bemotrizinol to the OTC monograph, recognizing it as safe and effective. The FDA seeks public comments on this proposal before finalizing the order.

This press release from the U.S. Food and Drug Administration announces the approval of Augmentin XR under the Commissioner's National Priority Voucher pilot program. It highlights the expedited approval process, which aims to reinforce domestic antibiotic manufacturing and address systemic drug shortages in the U.S. The program seeks to enhance the U.S. drug supply chain and address critical national health priorities.

This is an official press release from the U.S. Food and Drug Administration announcing the approval of Waskyra, the first gene therapy for treating Wiskott-Aldrich syndrome. The announcement details the therapeutic indications, the transformative impact of the approval, and regulatory considerations that facilitated this development. Key stakeholders from the FDA provide statements on the significance of this approval for patients suffering from this rare genetic disease.

This FDA press release announces the approval of Omisirge (omidubicel-onlv), the first cellular therapy for severe aplastic anemia. The therapy, based on chemically enhanced umbilical cord blood stem cells, is offered for adults and pediatric patients with this rare blood disorder who lack compatible donors. The approval represents a significant advancement in treatment options, with Omisirge expected to shorten recovery times and improve infection rates for patients.

The document is a public notice from the Food and Drug Administration (FDA) announcing a new pilot program called Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices. The program is designed to promote access to digital health devices while focusing on patient outcomes, in conjunction with the CMMI ACCESS model. It outlines the participation criteria and procedures for manufacturers seeking to engage in this pilot initiative beginning January 2, 2026.

This press release from the U.S. Food and Drug Administration announces the approval of Breyanzi (Lisocabtagene maraleucel) as the first CAR T-Cell therapy for treating adults with marginal zone lymphoma who have failed or relapsed after multiple therapies. The release highlights the significance of this precision medicine advancement and notes the FDA's commitment to enhancing treatment options for rare cancers. Important study results and the trial's context are provided, along with comments from FDA officials emphasizing the impact of this approval in oncology.

The U.S. Food and Drug Administration (FDA) announced the approval of Avance, an acellular nerve allograft by Axogen Corporation, designed to treat sensory nerve discontinuities. This press release details the approval criteria, the benefits over traditional methods, and the conditions under which Avance can be used. It highlights the FDA's regulatory flexibility in allowing the approval for broader uses under the Accelerated Approval pathway, subject to confirmatory trials.

The document is a press release from the U.S. Food and Drug Administration announcing the appointment of Tracy Beth Høeg, M.D., Ph.D., as the acting director of the Center for Drug Evaluation and Research (CDER). Dr. Høeg brings a background in medicine and epidemiology, having previously been a Visiting Scholar at MIT and serving various roles at the FDA. The FDA also announced Karen Murry, M.D., as the new director of the Office of Nonprescription Drugs.

This is an advisory document from the U.S. Food & Drug Administration, warning about the dangers of 7-hydroxymitragynine (7-OH), a concentrated opioid found in kratom products. The advisory highlights the potency of 7-OH, its increased prevalence in products, and the associated health risks, including addiction and fatal respiratory depression. The FDA is taking regulatory actions and collaborating with the DEA to control its distribution.