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Theratechnologies reçoit de la FDA la date cible d’approbation de mars 2025 à la licence de produit biologique mise à jour pour la formulation F8 de la tésamoréline
10. Dezember 2024 15:15 ET | Theratechnologies
MONTRÉAL, 10 déc. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (« Theratechnologies » ou la « Société ») (TSX : TH) (NASDAQ : THTX), une société biopharmaceutique axée sur la mise au...
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Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA
10. Dezember 2024 15:15 ET | Theratechnologies
MONTREAL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...
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Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates
12. November 2024 16:30 ET | Checkpoint Therapeutics, Inc
Biologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc....
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FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
24. September 2024 08:00 ET | Arcutis Biotherapeutics, Inc.
Arcutis today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for scalp and body psoriasis.
FILSPARI (sparsentan)
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
05. September 2024 17:34 ET | Travere Therapeutics, Inc.
Travere Therapeutics announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to treat IgA nephropathy.
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Zevra Therapeutics to Report Second Quarter 2024 Financial Results
30. Juli 2024 08:38 ET | Zevra Therapeutics
CELEBRATION, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced that it will host a...
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Zevra Announces FDA Advisory Committee Meeting to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C
09. Juli 2024 09:00 ET | Zevra Therapeutics
CELEBRATION, Fla., July 09, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and...
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Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
18. März 2024 08:30 ET | Journey Medical Corporation
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily...
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XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
15. März 2024 15:34 ET | Optinose, Inc.
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps Clinical...
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Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results
29. Februar 2024 16:40 ET | Optinose, Inc.
YARDLEY, Pa., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced...