Pleco Therapeutics receives FDA Orphan Drug Designation
January 16, 2024 11:30 ET
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Pleco Therapeutics B.V.
The U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics BV’s lead compound, PTX-252 for the treatment of AML.
Clearmind Medicine Completed Type A Meeting with the FDA
January 10, 2024 07:18 ET
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Clearmind Medicine Inc.
Tel Aviv, Israel / Vancouver, Canada, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on...
SOHM Files Provisional Patent on ABBIE’s ‘Smart Gene-Editing’ That Uses Latest Enzymes and Guide RNA to Resolve Off-Target Gene-Editing Limitations
January 09, 2024 09:30 ET
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SOHM, Inc.
CHINO HILLS, Calif., Jan. 09, 2024 (GLOBE NEWSWIRE) -- via IBN -- SOHM, Inc. (OTC PINK: SHMN) (the “Company”), a pharmaceutical, nutraceutical, cosmeceutical and biotech Company that manufactures...
AAMI and FDA Co-Sponsor Medtech Conference, ‘AAMI and FDA neXus'
January 08, 2024 09:37 ET
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AAMI
Arlington, VA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is delighted to welcome the U.S. Food and Drug Administration as an official...
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...
Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol
January 04, 2024 08:30 ET
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Avenue Therapeutics
MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of...
Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients
January 02, 2024 08:35 ET
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Pasithea
Pasithea's IND for PAS-004, a novel MEK inhibitor, is FDA-approved for Phase 1 trials in advanced cancer, starting Q1 2024 with early results by Q3.
Daxor Corporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer
January 02, 2024 08:30 ET
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Daxor Corporation
The New BVA System is Designed to be Significantly Faster, Simpler and Give Results at the Bedside Oak Ridge, TN, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global...
Theratechnologies soumet une demande supplémentaire de licence de produit biologique (sBLA) à la FDA pour l’administration intramusculaire (IM) de Trogarzoᴹᴰ
January 02, 2024 07:30 ET
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Theratechnologies
L’administration intramusculaire de la dose de maintien de TrogarzoMD vise à offrir des traitements pratiques qui ne sont pas administrés par voie orale aux adultes vivant avec le VIH qui ont déjà...
Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA
January 02, 2024 07:30 ET
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Theratechnologies
Trogarzo® IM maintenance dosing aims to further enhance the convenience of non-oral therapy for heavily treatment-experienced adults with HIV Submission comes on the heels of the recent FDA approval...