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Maroc Maroc - DRUGS.COM - New Drug Applications - 09/Aug 21:08

Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD

SAN JOSE, Calif., Aug. 9, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") 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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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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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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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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Merakris Therapeutics Announces FDA Clearance for Part 2 of its Phase II Multicenter Investigational New Drug Study of Dermacyte® Liquid

healthtechzone.com - 05/Sep 10:30

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Merakris Therapeutics Announces FDA Clearance for Part 2 of its Phase II Multicenter Investigational New Drug Study of Dermacyte® Liquid

healthtechzone.com - 05/Sep 10:30

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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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