Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved
13 août 2024 07h45 HE
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Cingulate Inc.
FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025Licensing Activity Continues KANSAS CITY, Kan., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a...
60 Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA® NDA in Support of SJ733 Phase IIb Study
12 août 2024 09h12 HE
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Sixty Degrees Pharmaceuticals
60 Degrees Pharma grants U of Kentucky a right of reference to ARAKODA® NDA for a Phase IIb trial combining SJ733 with tafenoquine to treat vivax malaria.
PharmAla Comments on USFDA Decision regarding MDMA-Assisted Therapy and Announces Patent Granting for ALA-002
09 août 2024 18h18 HE
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PharmAla Biotech
PharmAla expresses disappointment in USFDA's decision to request a third Phase 3 for MDMA and announces the patent granting for a safer MDMA analog variant
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
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...
Crossject poursuit sa stratégie de développement aux États-Unis et publie ses résultats financiers pour 2023
02 avr. 2024 04h30 HE
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CROSSJECT
Amélioration notable de la visibilité sur les perspectives règlementaires et commerciales aux États-Unis depuis les derniers échanges avec la FDA. Attente d’une obtention de l’Autorisation...
Crossject advances in its U.S. Strategy and reports Financial Results for 2023
02 avr. 2024 04h30 HE
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CROSSJECT
Increase in visibility in its regulatory and commercialization prospects in the U.S. since latest interactions with the FDAExpectation to receive U.S. Emergency Use Authorization (EUA) for ZEPIZURE®...
Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
07 mars 2024 08h00 HE
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Phathom Pharmaceuticals
Launched VOQUEZNA® (vonoprazan) tablets in November 2023 for the treatment of Erosive GERD (gastroesophageal reflux disease), achieving net revenues of $0.7 million for the fourth quarter Early...
Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
05 janv. 2024 08h30 HE
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Journey Medical Corporation
If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea NDA submission supported by positive Phase...