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...
MAPS Celebrates Submission of New Drug Application to FDA for MDMA-Assisted Therapy for PTSD
13 déc. 2023 18h16 HE
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Multidisciplinary Association for Psychedelic Studies (MAPS)
The first NDA submission for any psychedelic-assisted therapy has been submitted through a 30-year effort initiated and led by the nonprofit MAPS
AXSM FINAL DEADLINE ALERT: ROSEN, A LEADING LAW FIRM, Encourages Axsome Therapeutics, Inc. Investors to Secure Counsel Before Important December 7 Deadline in Securities Class Action – AXSM
24 nov. 2023 16h10 HE
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The Rosen Law Firm PA
NEW YORK, Nov. 24, 2023 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds investors of the common stock of Axsome Therapeutics, Inc. (“Axsome”) (NASDAQ: AXSM) of...
Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD
26 sept. 2023 08h01 HE
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Phathom Pharmaceuticals
Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile...