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Maroc Maroc - DRUGS.COM - New Drug Approvals - 25/Jul 01:07

Mirum’s Livmarli Now Approved for PFIC in Patients 12 Months and Older

FOSTER CITY, Calif.--(BUSINESS WIRE) July 25, 2024 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Livmarli (maralixibat) oral solution for the...

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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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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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Mirum Pharmaceuticals (MIRM) Up 4.5% Since Last Earnings Report: Can It Continue?

zacks.com - 06/Sep 15:31

Mirum Pharmaceuticals (MIRM) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

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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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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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Zynex Stock Rises on FDA Clearance of Its New Pain Management Device

zacks.com - 04/Sep 12:32

ZYXI recently received the Food and Drug Administration clearance for its new TensWave device. TensWave is designed to provide a comprehensive pain...

A More Efficient FDA Approval Process: An Expert’s Proposal

theparadise.ng - 06/Sep 00:50

The Food and Drug Administration (FDA), as many are aware, is the leading entity for the regulation and safety testing for foods and pharmaceuticals...