Crossject poursuit sa stratégie de développement aux États-Unis et publie ses résultats financiers pour 2023
April 02, 2024 04:30 ET
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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
April 02, 2024 04:30 ET
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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
March 07, 2024 08:00 ET
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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
January 05, 2024 08:30 ET
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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
December 13, 2023 18:16 ET
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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
November 24, 2023 16:10 ET
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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
September 26, 2023 08:01 ET
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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...
Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
August 21, 2023 08:00 ET
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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...
Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
July 17, 2023 09:00 ET
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Elevar Therapeutics
FORT LEE, N.J., July 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., and a fully integrated biopharmaceutical company dedicated to elevating...
Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
June 12, 2023 08:01 ET
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Phathom Pharmaceuticals
Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023Combined launch of vonoprazan for Erosive GERD and H. pylori indications planned for Q4 2023, if approved FLORHAM PARK, N.J., June...