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 déc. 2024 15h15 HE
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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
10 déc. 2024 15h15 HE
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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
12 nov. 2024 16h30 HE
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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
24 sept. 2024 08h00 HE
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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
05 sept. 2024 17h34 HE
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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
30 juil. 2024 08h38 HE
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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
09 juil. 2024 09h00 HE
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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
18 mars 2024 08h30 HE
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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
15 mars 2024 15h34 HE
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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
29 févr. 2024 16h40 HE
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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...