On July 16, 2025 MAA Laboratories reported that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, JUL 16, 2025, View Source [SID1234654403]).
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The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont platform.
"We are grateful for BfArM’s constructive guidance," said Dr. Anjani Jha, CEO of MAA Laboratories. "The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies."
MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.