FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD
May 21, 2024 09:00 ET | Cingulate Inc.
Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application Advancing Discussions with Commercialization Partners
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PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy
May 07, 2024 08:30 ET | 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...
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Crossject poursuit sa stratégie de développement aux États-Unis et publie ses résultats financiers pour 2023
April 02, 2024 04:30 ET | 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...
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Crossject advances in its U.S. Strategy and reports Financial Results for 2023
April 02, 2024 04:30 ET | 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
March 07, 2024 08:00 ET | 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...
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Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
January 05, 2024 08:30 ET | 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 The first NDA submission for any psychedelic-assisted therapy has been submitted through a 30-year effort initiated and led by the nonprofit MAPS
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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
November 24, 2023 16:10 ET | 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
September 26, 2023 08:01 ET | 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...
Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
August 21, 2023 08:00 ET | Phathom Pharmaceuticals
Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf lifeSubmission of...