PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
23 oct. 2024 08h00 HE
|
PharmaTher Holdings Ltd.
TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food...
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
12 sept. 2024 08h30 HE
|
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 Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved
13 août 2024 07h45 HE
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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®...