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NMDA receptors regulate GABA A receptor lateral mobility and clustering at inhibitory synapses through serine 327 on the 2 subunit

With respect to the substantial similarity criteria, the applicant asserted that TECVAYLI TM is not substantially similar to other currently available technologies because it has a distinct mechanism of action, with a novel approach to engage a patient's own T-cells to generate a myeloma-specific immune response, and is the first therapy of its type for the treatment of RRMM, and therefore meets the newness criterion

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FSSAI sets the regulatory baseline

Refrigerated storage is preferred because it avoids unnecessary freezing and reduces the likelihood of repeated freezethaw cycles that can occur when vials are removed from and returned to the freezer