The FDA is making a habit of delivering Intra-Cellular Therapies an early Christmas present. Two years ago, on Dec. 23, the U.S. regulator approved Intra-Cellular’s first product, Caplyta, for ...
The approval was supported by data from two phase 3 studies that evaluated Caplyta as monotherapy and adjunctive therapy with lithium or valproate in adults with bipolar depression. The Food and Drug ...
The FDA approved lumateperone (Caplyta) for bipolar-related depressive episodes, Intra-Cellular Therapies announced Monday. The atypical antipsychotic gained an indication for the treatment of ...
The US Food and Drug Administration (FDA) has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as ...
TITUSVILLE, N.J., April 27, 2026 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on ...
NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central ...
Q3 2023 total revenues increased to $126.2 million, compared to $71.9 million in the same period in 2022 CAPLYTA Q3 2023 net product sales were $125.8 million, compared to $71.9 million for the same ...
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