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Despite already being approved for these patients, investors should care because the company is seeking to expand its supplemental New Drug Application [sNDA] label to include patients as young as ...
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ITCI Submits sNDA to the FDA for Expanded Use of Caplyta in MDDThe sNDA submission is supported by positive results from two late-stage studies, Studies 501 and 502, that evaluated 42 mg of lumateperone as an adjunctive therapy to antidepressants for MDD ...
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AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded UseAstraZeneca AZN announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
How so? Well, the FDA not only accepted its supplemental New Drug Application [sNDA] of Cabometyx for the treatment of patients with advanced neuroendocrine tumors [NET], but gave a PDUFA date of ...
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...
A SUBORDINATION, Non-Disturbance and Attornment Agreement, or SNDA, is an agreement among a tenant, a landlord, and the landlord’s lender. The landlord’s lender, or mortgagee, is the bank ...
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