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754,490 Results for "fabre kramer pharmaceuticals inc".
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FDA
FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
May 7, 2026
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3 min read
·
Heather McKenzie
Press Releases
Helus Pharma Strengthens Medical Leadership by Appointing Dr. Ken Kramer as Senior Vice President, Medical Affairs
April 16, 2026
·
7 min read
Press Releases
Aytu BioPharma Announces Exclusive Agreement with Fabre-Kramer Pharmaceuticals to Commercialize First-in-Class Antidepressant EXXUA(TM) (gepirone) Extended-Release Tablets in the United States
June 9, 2025
·
9 min read
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
·
6 min read
Press Releases
Pierre Fabre Pharmaceuticals Announces Regulatory Update Following Type A Meeting with U.S. Food and Drug Administration (FDA) on Tabelecleucel Biologic License Application (BLA)
May 7, 2026
·
3 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
·
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
·
3 min read
Press Releases
Pierre Fabre Pharmaceuticals Announces Type A Meeting Agreed with U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA)
March 12, 2026
·
2 min read
Press Releases
Pierre Fabre Pharmaceuticals Submits Type A Meeting Request to U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA)
March 3, 2026
·
2 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
·
1 min read
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