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Maroc Maroc - ZACKS.COM - All Stories - 05/Sep 15:35

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

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

zacks.com - 11/Sep 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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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...

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Corcept Shares Rise More Than 45% in Six Months: Here's Why

zacks.com - 03/Sep 15:28

CORT's Cushing's syndrome drug, Korlym, has been performing well. The NDA for lead candidate, relacorilant, in Cushing's syndrome will be filed...

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Axis Capital (AXS) Is Up 4.28% in One Week: What You Should Know

zacks.com - 05/Sep 16:00

Does Axis Capital (AXS) have what it takes to be a top stock pick for momentum investors? Let's find out.

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FDA extends review period for Medexus’ treosulfan to 2025

themarketherald.ca - 17:41

Medexus Pharmaceuticals (TSX:MDP) reveals the U.S. FDA has extended the review period for the company's new drug application for treosulfan.