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Abivax Announces Positive Pre-NDA Interaction with the FDA for Obefazimod Company remains on track to submit its first New Drug Application for obefazimod for the treatment of moderately to severely...
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Abivax annonce un retour positif de la FDA à l’issue de ses échanges pré-NDA concernant l’obéfazimod
Abivax annonce un retour positif de la FDA à l’issue de ses échanges pré-NDA concernant l’obéfazimod La Société confirme être en bonne voie pour déposer, d’ici la fin de l’année 2026, sa première...
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Dr Falk and Renexxion commit to late-stage development following naronapride’s positive P2b results in gastroparesis, a disease with high unmet need.
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This is the first NDA acceptance for BTK inhibitor orelabrutinib in autoimmune diseases. No BTK inhibitors have been approved in China for ITP.
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FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for CNM-Au8 based on neurofilament light (NfL) biomarker...
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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...
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In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter...
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FORT LEE, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
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Biosplice announces submission of new drug application to US FDA for treatment of knee osteoarthritis
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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....