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617,353 Results for "food and drug administration fda".
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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
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
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2 min read
Press Releases
Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease
April 22, 2026
·
5 min read
Press Releases
Savara Announces the U.S. Food & Drug Administration (FDA) Has Extended the Review Period for the Molgramostim Inhalation Solution (Molgramostim) Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
April 16, 2026
·
4 min read
Press Releases
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
June 1, 2026
·
17 min read
Press Releases
BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting
April 1, 2026
·
10 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
February 20, 2026
·
13 min read
Press Releases
Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
February 22, 2026
·
5 min read
Policy
FDA turns to old drugs to address new diseases, persistent medical needs
The FDA is looking to retool drugs with sufficient evidence to support their use in other indications, particularly those with unmet need.
May 12, 2026
·
2 min read
·
Tristan Manalac
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