RadioMedix Announces Receiving FDA Approval of its Generic Ga-68 PSMA-11 Radiodiagnostic for Prostate Cancer
Approval follows FDA inspection of RadioMedix’s manufacturing site with no Form 483 observations, underscoring the Company’s radiopharmaceutical manufacturing and quality capabilities
HOUSTON, June 10, 2026 (GLOBE NEWSWIRE) -- RadioMedix, Inc., a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and cancer therapy, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s GALLIUM GA 68 GOZETOTIDE INJECTION, also known as Ga 68 PSMA-11, a prostate-specific membrane antigen (PSMA)-targeted diagnostic radiopharmaceutical for positron emission tomography (PET) imaging in patients with prostate cancer. In connection with the approval, RadioMedix also completed an FDA inspection of its manufacturing site known as The SPICA Center located north of Houston, TX with no Form 483 observations.
Ga-68 PSMA-11 is a radioactive diagnostic agent that targets PSMA, a protein commonly expressed in prostate cancer. The approval expands RadioMedix’s precision nuclear medicine portfolio and supports the Company’s continued work to advance diagnostic radiopharmaceuticals for patients and physicians.
“FDA approval of our Ga68 PSMA-11 Abbreviated New Drug Application (ANDA) represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost effective and high-quality radiopharmaceuticals for patients,” said Ebrahim S. Delpassand, M.D., Founder and Chief Executive Officer of RadioMedix. “We are also proud to have completed the FDA inspection with no Form 483 observations, which reflects the rigor of our quality systems, manufacturing capabilities, and teamwide commitment to regulatory excellence. As the radiopharmaceutical field continues to grow, quality, consistency, and regulatory readiness will be essential to ensuring these technologies can reliably reach patients.”
The SPICA Center consist of a 27,500 sq. ft. radiopharmaceutical manufacturing facility, multiple clean rooms, fully equipped quality control suites, a strong quality assurance backbone, and 21 CFR 211 compliance supporting the development and production of targeted diagnostic and therapeutic radiopharmaceuticals for internal programs and external partners.
Connie Chang, Head of Quality at RadioMedix, added, “Successfully completing the FDA inspection with no Form 483 observations reflects more than a single milestone — it represents RadioMedix’s enduring commitment to a strong quality culture across the organization. This achievement is the result of sustained senior management support, cross-functional collaboration, and a company-wide dedication to quality, compliance, and continuous improvement. At RadioMedix, quality is not only a regulatory requirement, but a core value that guides our operations, strengthens our manufacturing and quality systems, and ultimately supports the reliable delivery of safe and high-quality radiopharmaceuticals to patients.”
About Ga-68 PSMA-11 Injection
Ga-68 PSMA-11 Injection is a radioactive diagnostic agent for PET imaging of PSMA-positive lesions in patients with prostate cancer.
Important Safety Information
Please see safety information for GALLIUM GA 68 GOZETOTIDE INJECTION at https://radiomedix.com/drug-discovery/#isi.
Please see full Prescribing Information for GALLIUM GA 68 GOZETOTIDE INJECTION at https://radiomedix.com/wp-content/uploads/2026/06/1-14-1-3-rmx-psma-uspi-05-2024-master-1.pdf.
About RadioMedix
RadioMedix, Inc. is a clinical-stage biotechnology company advancing precision solutions in nuclear medicine with a focus on targeted radiopharmaceuticals for the diagnosis, monitoring, and therapy of hard-to-treat cancers with high unmet need. The Company’s pipeline includes best-in-class radiopharmaceuticals for PET imaging and radionuclide therapy, with a focus on progressing the next generation of Targeted Alpha Therapies (TAT). To support its operations, RadioMedix built The SPICA Center, a self-sufficient, state-of-the-art 27,500 sq. ft. facility that is leading the industry in radiopharmaceutical manufacturing and offers full-service support for academic and industry partners. For more information, visit https://radiomedix.com/ and follow us on LinkedIn.
RadioMedix Contact
info@radiomedix.com
Media Contact
Krista Celo
LifeSci Communications
RadioMedixLSC@lifescicomms.com
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