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Maroc Maroc - DRUGS.COM - Pharma Industry News - 11/Jul 22:12

FDA Approves Zoryve for Atopic Dermatitis

THURSDAY, July 11, 2024 -- The U.S. Food and Drug Administration has approved Zoryve (roflumilast) cream, 0.15 percent, for the treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients (ages 6 years and older).Zoryve is a...

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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 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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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 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 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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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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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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