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Maroc Maroc - DRUGS.COM - New Drug Applications - 28/Aug 03:08

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

MELBOURNE, Australia, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for...

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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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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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Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

drugs.com - 05/Sep 05:09

SAN DIEGO, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration...

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Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

drugs.com - 05/Sep 05:09

SAN DIEGO, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration...

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Indies Pharma looking to double sales after securing FDA drug approval

jamaica-gleaner.com - 11/Sep 05:05

Drug company Indies Pharma Jamaica Limited is looking to double next year’s revenues, following approval of its abbreviated new drug application,...

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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.

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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.

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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...

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U.S. lawmakers call out FDA for slow ‘smoke-free’ product review amid growing illegal market

westernstandardonline.com - 13/Sep 17:50

U.S. lawmakers and health groups are upset about how the Food and Drug Administration (FDA) is handling e-cigarettes and other smoke-free products.

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