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583,383 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
·
3 min read
·
Heather McKenzie
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
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
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
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
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 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
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
·
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 STATEMENT REGARDING RECEIPT OF COMPLETE RESPONSE LETTER FOR TABELECLEUCEL BIOLOGICS LICENSE APPLICATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION
January 12, 2026
·
4 min read
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