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May 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...
April 03, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301

KANSAS CITY, Kan., April 03, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
May 01, 2023 07:00 ET | Source: Minerva Neurosciences, Inc

Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

BURLINGTON, Mass., May 01, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
August 22, 2022 08:00 ET | Source: Minerva Neurosciences, Inc

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
January 30, 2019 08:00 ET | Source: IntelGenx Technologies Corp.

IntelGenx Facility Undergoes U.S. FDA Pre-Approval Inspection Related to RIZAPORT® NDA

SAINT LAURENT, Quebec, Jan. 30, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced that the U.S. Food and Drug...
September 24, 2018 08:00 ET | Source: IntelGenx Technologies Corp.

IntelGenx Announces Successful Results from RIZAPORT® Bioequivalence Study

SAINT LAURENT, Quebec, Sept. 24, 2018 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) today announced successful results from a bioequivalence study for...