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Maroc Maroc - FINANCIALPOST.COM - A La Une - 09/Aug 22:29

PsyCan Comments on FDA Decision Re: Lykos MDMA-Assisted Therapy Application

OTTAWA, Ontario, Aug. 09, 2024 (GLOBE NEWSWIRE) — PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine, today commented on the U.S. Food and Drug Administration (“FDA”) decision on the New Drug Application by Lykos Therapeutics for MDMA and MDMA-assisted therapy to treat PTSD. “While the FDA’s decision is a setback for the […]

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ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

zacks.com - 16:04

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

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Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

drugs.com - 03/Sep 01:09

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab

zacks.com - 30/Aug 16:07

The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of...

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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KalVista announces FDA acceptance of NDA for sebetralstat for oral on-demand treatment of HAE

haei.org - 03/Sep 17:29

KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...

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Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia Gravis

drugs.com - 29/Aug 23:08

Spring House, Pa. (August 29, 2024) – Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and...

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FDA Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up

zacks.com - 05/Sep 15:35

The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

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EcoWaste Coalition Thumbs Up FDA’s Action vs. Indonesia-Made Skin Whitening Cream

journal.com.ph - 04/Sep 11:54

Quezon City. The toxics watchdog group EcoWaste Coalition gave the Food and Drug Administration (FDA) a pat on the back for its recent move to...

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