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FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
March 26, 2025 09:45 ET
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AAMI
Arlington, VA, March 26, 2025 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that the FDA has amended its database of Recognized Consensus Standards, adding multiple AAMI documents in the agency’s...
Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia
March 26, 2025 03:00 ET
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Pleco Therapeutics B.V.
Pleco Therapeutics announces positive FDA feedback on PTX-252, supporting IND pathway for its novel AML treatment.
Theratechnologies reçoit l’approbation de la FDA pour EGRIFTA WR(MC) (la formulation F8 de la tésamoréline) pour traiter l’excès de graisse viscérale abdominale chez les adultes vivant avec le VIH atteints de lipodystrophie
March 25, 2025 17:45 ET
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Theratechnologies
Une nouvelle formulation améliorée remplacera EGRIFTA SVMD MONTRÉAL, 25 mars 2025 (GLOBE NEWSWIRE) -- Theratechnologies inc. (« Theratechnologies » ou la « Société ») (TSX : TH) (NASDAQ :...
Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
March 25, 2025 17:45 ET
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Theratechnologies
New, improved formulation set to replace EGRIFTA SV® MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a...
Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
March 25, 2025 08:30 ET
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Genelux Corporation
- U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval - WESTLAKE VILLAGE, Calif., March ...
Abinopharm, Inc. warmly congratulates partner company EGT Synbio on receiving no objection letter from the FDA for their GRAS notification of Dr.Ergo®Ergothioneine
March 24, 2025 15:35 ET
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Abinopharm, Inc.
Abinopharm, Inc. and our partner, EGT Synbio, announced our Ergothioneine ingredient received GRAS status from FDA, the 2nd GRAS for Ergothioneine in US.
KRTL Holding Group Announces KRTL Biotech Inc. Signs MOU with Industria Químico Farmacéutica Sigma Corp. S.R.L. to Pursue Strategic International Merger
March 24, 2025 09:00 ET
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KRTL Holding Group
Lakewood, CO, March 24, 2025 (GLOBE NEWSWIRE) -- KRTL Holding Group Inc. (OTC: KRTL), a diversified holding company operating through its subsidiaries KRTL Biotech, Inc. and KRTL International...
Lexeo Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
March 24, 2025 07:00 ET
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Lexeo Therapeutics
Lexeo Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
Clearmind Medicine’s FDA-Approved Clinical Trial for CMND-100 Moves Forward as Drug Arrives in the U.S., Advancing Toward Key Milestones
March 21, 2025 09:28 ET
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Clearmind Medicine Inc.
Vancouver, Canada, March 21, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and...
Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease
March 20, 2025 09:00 ET
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Longeveron
Longeveron reaches alignment with US FDA on single, pivotal clinical trial to BLA submission for cell therapy for treatment of Alzheimer's disease.