FDA launches effort to review infant formulas
The Food and Drug Administration (FDA) on Tuesday announced a new initiative titled 'Operation Stork Speed' aimed at reviewing infant formula ingredients and expanding available options.
According to the FDA, the goal of its new initiative is to ensure the 'quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.'
In 2022, the U.S. infant formula supply was crippled following the temporary closure of Abbott Nutrition's Michigan facility due to bacteria contamination. The FDA shut down the facility for months and a nationwide recall was issued.
'The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,' Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement, calling this action 'critical' to his Make America Healthy Again agenda.
The FDA's response to the 2022 infant formula crisis has been scrutinized, with the Office of Inspector General for the Department of Health and Human Services (HHS) finding that the agency was dangerously slow in responding to complaints about conditions at the facility. The blowback from this led in part to the FDA reorganizing its structure in 2024.
In its announcement Tuesday, the FDA listed a set of actions it says will support nutritional adequacy and supply of infant formula. These include conducting the 'first comprehensive update and review of infant formula nutrients by the FDA since 1998,' increasing testing for heavy metals and extending the personal importation policy.
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NIH scientists speak out over estimated $12 billion in Trump funding cuts
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TuHURA Biosciences Presents IFx-Hu2.0 Trial-in-Progress Poster at the 2025 American Society of Clinical Oncology Annual Meeting
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While checkpoint inhibitor therapy has markedly improved the outcome for patients with advanced or metastatic MCC, unfortunately for patients who don't respond to first line checkpoint inhibitor therapy the survival is poor at less than 30 months.1 Based on the results from our Phase 1 clinical trials, IFx-Hu2.0 intralesional administration has demonstrated it can activate an innate immune response, resulting in the production and activation of tumor specific B cells and T cells, to overcome the primary CPI resistance in both advanced or metastatic MCC or melanoma," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "We believe we have provided data requested by the FDA that addresses the requirements listed in the partial clinical hold letter to allow us to initiate our Phase 3 accelerated approval trial this month. The FDA was constructive in the trial design, which can potentially satisfy both the requirements for accelerated and regular approval without the requirements for a post approval confirmatory trial. They continue to work with us under the SPA Agreement in preparing the trial's initiation." In the Phase 1b trial of IFx-Hu2.0, MCC among patients who progressed on pembrolizumab (anti-PD-1) or avelumab (anti-PDL-1) therapy, weekly administration of IFx-Hu2.0 for up to 3 doses followed by rechallenge with anti-PD(L)-1 therapy, demonstrated an overall response rate of 63% (2CR, 5 PR) with duration of responses ranging from 6 to 33 months with 5 ongoing responses as of last follow-up in June 2024. The Company's Phase 3 accelerated approval trial of adjunctive IFx-Hu2.0, to be conducted under a SPA agreement with the U.S. FDA, will evaluate IFx-Hu2.0 (0.1 mg) as an adjunctive therapy administered weekly for three weeks concurrent to pembrolizumab (200 mg) Q3W, compared to the same pembrolizumab regimen plus placebo. The pivotal trial is expected to enroll 118 CPI-naïve patients with advanced or metastatic MCC across approximately 22 to 25 U.S. sites. Trial participants will be randomized on a 1:1 basis and receive CPI therapy for up to two years, or until disease progression or CPI related toxicities. The primary endpoint for the trial is overall response rate (ORR) with a key secondary endpoint of progression free survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival. The Trial in Progress poster is available on the Scientific Publications page of TuHURA's website. 1 Kacew et al. (2020). Predictors of immunotherapy benefit in Merkel cell carcinoma. Oncotarget, 11(47), 4401–4410. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit and connect with TuHURA on Facebook, X, and LinkedIn. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial and any developments or results in connection therewith and the anticipated regulatory pathway and timing thereof. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique KosseGilmartin GroupMonique@ View original content to download multimedia: SOURCE TuHURA Biosciences, Inc. 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