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Maroc Maroc - DRUGS.COM - New Drug Approvals - 22/Jul 20:07

FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli® (eculizumab-aagh) as a...

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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

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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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Telix Submits NDA for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent

drugs.com - 28/Aug 03:08

MELBOURNE, Australia, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted...

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FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN

drugs.com - 28/Aug 01:09

STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused...

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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....

‘Significant milestone’ – EBR submits final PMA module to FDA

stockhead.com.au - 29/Aug 21:21

EBR Systems has submitted the final premarket approval (PMA) application module to the US Food and Drug Administration (FDA) for ...

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FDA Clears First Automated Device to Deliver Insulin to People With Type 2 Diabetes

drugs.com - 27/Aug 12:01

TUESDAY, Aug. 27, 2024 -- The U.S. Food and Drug Administration on Monday approved the expanded use of an automated insulin pump system to include...

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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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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...