Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
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N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects
The new service delivers end-to-end support, managing every stage of an epigenomics project
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