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Maroc Maroc - ZACKS.COM - All Stories - 04/Sep 15:37

Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS II and its subsequent conversion to full approval.

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Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

zacks.com - 04/Sep 15:37

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

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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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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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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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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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Meeting planned on alternative to poppy farming: UN

pajhwok.com - 05/Sep 06:01

Special Representative of the Secretary-General and UNAMA head Roza Otunbayeva has announced that efforts are underway to organise a joint meeting on...

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Meeting planned on alternative to poppy farming: UN

pajhwok.com - 05/Sep 06:01

Special Representative of the Secretary-General and UNAMA head Roza Otunbayeva has announced that efforts are underway to organise a joint meeting on...