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705,221 Results for "fabre kramer pharmaceuticals inc".
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FDA
Fabre-Kramer Pharmaceuticals Announces FDA Approval of EXXUA™, the First and Only Oral Selective 5HT1a Receptor Agonist for the Treatment of Major Depressive Disorder in Adults
Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Exxua™ (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.
September 28, 2023
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6 min read
FDA
Fabre-Kramer Finally Gets FDA Approval for MDD Drug After Decades-Long Quest
After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
September 29, 2023
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2 min read
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Tristan Manalac
Lone Star Bio
Fabre-Kramer Submits NDA Amendment for EXXUA™ for Treatment of Major Depressive Disorder
Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUA™ (gepirone ER) for treatment of Major Depressive Disorder (MDD).
January 4, 2023
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3 min read
Lone Star Bio
Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date
HOUSTON, Jan. 24, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals announced today it received on January 20, 2023 acknowledgement and acceptance of its December 23, 2022 NDA Amendment for EXXUA (gepirone hydrochloride) extended release tablets for the treatment of Major Depressive Disorder (MDD).
January 24, 2023
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1 min read
Press Releases
Kaitie Kramer Joins Parse Biosciences as Vice President of Marketing
September 17, 2024
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2 min read
Business
Kinnate Biopharma Inc. Sells Its Investigational Pan-RAF Inhibitor, Exarafenib, to Pierre Fabre Laboratories
Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, and Pierre Fabre Médicament, SAS (“Pierre Fabre Laboratories”), a global player in oncology, today announced their agreement to the sale of the Company’s investigational pan-RAF inhibitor, exarafenib, and other pan-RAF program assets pursuant to the APA entered into by the parties.
March 1, 2024
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10 min read
Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA™ (vibegron) in overactive bladder.
The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients* in Europe.
June 28, 2024
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2 min read
Policy
Pierre Fabre Laboratories Announce IND Filing for PFL-002/VERT-002, a Potential Treatment for Patients with Solid Tumors, Including Non-Small Cell Lung Cancer with MET Alterations
Pierre Fabre Laboratories announced the filing of an investigational new drug application to the U.S. Food and Drug Administration to initiate a first-in-human Phase I/II clinical trial with PFL-002/VERT-002 for solid tumors including non-small cell lung cancer.
June 5, 2024
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2 min read
Pierre Fabre Laboratories receives the Galien International Prize for EBVALLO®, the first allogeneic immunotherapy for patients with a rare cancer
Pierre Fabre Laboratories has been awarded the “Prix Galien International” Prize in the “Best Product for a Rare/Orphan Disease” category for EBVALLO®.
June 21, 2024
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2 min read
Pierre Fabre Laboratories receive positive CHMP opinion for OBGEMSA™(vibegron) in overactive bladder syndrome
Pierre Fabre Laboratories receive positive CHMP opinion for OBGEMSA™(vibegron) in overactive bladder syndrome.
April 26, 2024
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4 min read
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