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
December 10, 2024 15:15 ET
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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...
Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA
December 10, 2024 15:15 ET
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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...
Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates
November 12, 2024 16:30 ET
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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....
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
September 24, 2024 08:00 ET
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Arcutis Biotherapeutics, Inc.
Arcutis today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for scalp and body psoriasis.
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
September 05, 2024 17:34 ET
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Travere Therapeutics, Inc.
Travere Therapeutics announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to treat IgA nephropathy.
Zevra Therapeutics to Report Second Quarter 2024 Financial Results
July 30, 2024 08:38 ET
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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...
Zevra Announces FDA Advisory Committee Meeting to Review Arimoclomol for the Treatment of Niemann-Pick Disease Type C
July 09, 2024 09:00 ET
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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...
Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
March 18, 2024 08:30 ET
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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...
XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
March 15, 2024 15:34 ET
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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...
Optinose Announces Reporting Date for Fourth Quarter 2023 Financial Results
February 29, 2024 16:40 ET
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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...