Final Study Completed for Cingulate’s Lead Asset CTx-1301
07 janv. 2025 07h30 HE
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Cingulate Inc.
No Serious Adverse Events ReportedSubmission of New Drug Application Targeted for Mid 2025 KANSAS CITY, Kan., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
06 janv. 2025 08h00 HE
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Fortress Biotech, Inc.
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones ...
Zevra’s MIPLYFFA™ (arimoclomol) Receives Approval from U.S. Food and Drug Administration for Use in Patients with Niemann-Pick Disease Type C (NPC)
23 sept. 2024 06h30 HE
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XOMA Corporation
MIPLYFFA(TM) becomes 6th commercial asset in XOMA Royalty's portfolio
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
12 sept. 2024 08h30 HE
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Cingulate Inc.
KANSAS CITY, Kan., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
25 juin 2024 09h20 HE
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Cingulate Inc.
Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug...
FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD
21 mai 2024 09h00 HE
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Cingulate Inc.
Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application
Advancing Discussions with Commercialization Partners
Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update
08 mai 2024 07h00 HE
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Cingulate Inc.
CTx-1301 on track to file for Marketing Approval with FDA in 1H 2025 Increase of $10 Million in Stockholders’ Equity KANSAS CITY, Kan., May 08, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:...
PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy
07 mai 2024 08h30 HE
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PaxMedica, Inc.
TARRYTOWN, New York, May 07, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (OTC:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, provided a...
Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
18 mars 2024 08h30 HE
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Journey Medical Corporation
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily...
Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)
13 mars 2024 07h55 HE
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Catalyst Pharmaceuticals, Inc.
AGAMREE® (vamorolone) a Novel Alternative Corticosteroid with Demonstrated Properties in Maintaining Efficacy and a Well-Tolerated Side Effect Profile Available in the U.S. by Prescription for...