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Maroc Maroc - DRUGS.COM - New Drug Approvals - 23/Jul 23:07

FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control Pill

On July 22, 2024, the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl...

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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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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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FDA Expands Approval of Omnipod 5 Insulin Delivery System to Include Patients With Type 2 Diabetes

drugs.com - 27/Aug 21:48

TUESDAY, Aug. 27, 2024 -- On Monday, the U.S. Food and Drug Administration approved the Insulet Omnipod 5 insulin delivery system for patients with...

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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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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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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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FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

thestar.com.my - 30/Aug 18:54

(Reuters) -The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID shot. Read...

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‘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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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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