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Maroc Maroc - ZACKS.COM - All Stories - 20/Aug 14:27

Liquidia (LQDA) Down on FDA Delaying Full Approval for Yutrepia

The FDA grants tentative approval to Liquidia's (LQDA) inhaled powder for two lung disorder indications. Full approval may be granted after May 2025, when the regulatory exclusivity of a competing product expires.

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Liquidia Technologies (LQDA) Soars 14.1%: Is Further Upside Left in the Stock?

zacks.com - 12/Sep 11:00

Liquidia Technologies (LQDA) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate...

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FDA Grants Label Expansion to J&J's Tremfya in Ulcerative Colitis

zacks.com - 12/Sep 15:39

With this latest approval, JNJ's Tremfya is approved for a total of three immunology indications.

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FDA Grants Label Expansion to J&J's Tremfya in Ulcerative Colitis

zacks.com - 12/Sep 15:39

With this latest approval, JNJ's Tremfya is approved for a total of three immunology indications.

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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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WHO grants first mpox vaccine approval to ramp up response to disease in Africa

jamaica-gleaner.com - 13/Sep 13:53

GENEVA (AP) — The World Health Organization said Friday it has granted its first authorisation for use of a vaccine against mpox in adults,...

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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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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...

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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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 09/Sep 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...