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16 avr. 2026 05h00 HE | Source: AiCuris Anti-infective Cures AG

Aicuris Receives FDA Priority Review for Pritelivir NDA and Presents New Phase 3 Data at ESCMID 2026

The U.S. Food and Drug Administration has granted Priority Review for Aicuris’ New Drug Application for pritelivir, a novel helicase primase inhibitor developed to treat refractory herpes simplex...
14 avr. 2026 07h30 HE | Source: Praxis Precision Medicines, Inc.

Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor

FDA assigned PDUFA target action date of January 29, 2027 No advisory committee meeting expected BOSTON, April 14, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully...
15 déc. 2025 08h00 HE | Source: Fortress Biotech, Inc.

Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission

MIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S....
25 mars 2025 17h45 HE | Source: Theratechnologies

Theratechnologies reçoit l’approbation de la FDA pour EGRIFTA WR(MC) (la formulation F8 de la tésamoréline) pour traiter l’excès de graisse viscérale abdominale chez les adultes vivant avec le VIH atteints de lipodystrophie

Une nouvelle formulation améliorée remplacera EGRIFTA SVMD MONTRÉAL, 25 mars 2025 (GLOBE NEWSWIRE) -- Theratechnologies inc. (« Theratechnologies » ou la « Société ») (TSX : TH) (NASDAQ :...
25 mars 2025 17h45 HE | Source: Theratechnologies

Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy

New, improved formulation set to replace EGRIFTA SV® MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a...
10 déc. 2024 15h15 HE | Source: Theratechnologies

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

MONTRÉAL, 10 déc. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (« Theratechnologies » ou la « Société ») (TSX : TH) (NASDAQ : THTX), une société biopharmaceutique axée sur la mise au...
10 déc. 2024 15h15 HE | Source: Theratechnologies

Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA

MONTREAL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...
12 nov. 2024 16h30 HE | Source: Checkpoint Therapeutics, Inc

Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

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....
24 sept. 2024 08h00 HE | Source: Arcutis Biotherapeutics, 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

Arcutis today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for scalp and body psoriasis.
05 sept. 2024 17h34 HE | Source: Travere Therapeutics, Inc.

Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy

Travere Therapeutics announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to treat IgA nephropathy.

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