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FDA

FDA
Auxilium Pharmaceuticals, VIVUS, Inc.'s Faster-Acting Erectile Dysfunction Drug Wins FDA Approval
September 18, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Baxter International, Inc., Halozyme Therapeutics, Inc.'s HYQVIA
September 15, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Panel Recommends Approval Of NPS Pharmaceuticals, Inc.'s Natpara To Treat Hypoparathyroidism
September 12, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Orexigen’s Long-Awaited Weight Loss Drug Contrave
September 11, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Keryx Biopharmaceuticals’ Kidney Drug Ferric Citrate With Warnings, Shares Crash
September 8, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Merck & Co.'s New-Kind Of Cancer Drug Keytruda
September 4, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Gaucher Disease Pill Cerdelga
August 19, 2014
 · 
2 min read
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FDA
FDA Approves Biogen Idec, Inc. (Massachusetts)'s Multiple Sclerosis Drug Plegridy
August 18, 2014
 · 
8 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Merck & Co. Wins FDA Approval For New Type Of Sleeping Pill
August 13, 2014
 · 
3 min read
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FDA
FDA Green Lights Boehringer Ingelheim Corporation, Eli Lilly and Company’s Jardiance For Type 2 Diabetes
August 1, 2014
 · 
2 min read
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PRESS RELEASES
Press Releases
Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor
May 7, 2026
 · 
4 min read
Press Releases
Mezzion Reports Pre-IND FDA Feedback on the Development of Udenafil in ADPKD
May 7, 2026
 · 
2 min read
Press Releases
Cadrenal Therapeutics Reports First Quarter 2026 Financial Results and Provides Phase 3 Development Update on CAD-1005 Following End-of-Phase 2 Meeting with FDA
May 7, 2026
 · 
8 min read
Press Releases
Repertoire Immune Medicines Announces FDA Fast Track Designation for its Investigational Immune Medicine, RPTR-1-201
May 7, 2026
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3 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
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3 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Clearance to Proceed with Clinical Trial of NRX-101 in Combination with Robotic-enabled Transcranial Magnetic Stimulation in Patients with Depression and Suicidality
May 7, 2026
 · 
5 min read
Press Releases
ArriVent Announces IND Clearance for Novel Tetravalent MUC16/NaPi2b Targeting ADC ARR-002 with Initial Focus in Ovarian and Endometrial Cancers
May 7, 2026
 · 
4 min read
Press Releases
Scienture Secures $11.0 Million in Non-Dilutive Debt Financing to Accelerate Growth of Approved Product Portfolio and Advancement of R&D Pipeline
May 7, 2026
 · 
11 min read
Press Releases
Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial
May 7, 2026
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11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
 · 
3 min read
Press Releases
Sight Sciences Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Revenue Guidance
May 7, 2026
 · 
15 min read
Press Releases
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
May 7, 2026
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2 min read
Press Releases
FDA Expands AI Capabilities and Completes Data Platform Consolidation
May 7, 2026
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2 min read
Press Releases
Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma
May 6, 2026
 · 
3 min read
Press Releases
Partner Therapeutics Announces Receipt of FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma
May 6, 2026
 · 
11 min read
Press Releases
Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer
May 6, 2026
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11 min read
Press Releases
BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer
May 6, 2026
 · 
4 min read
Press Releases
Avacta presents new comparisons of pre|CISION® payload release vs approved ADCs and AVA6207 dual payload delivery at Science Day 2026
May 6, 2026
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5 min read
Press Releases
Azenta Reports Second Quarter Results for Fiscal 2026, Ended March 31, 2026, Updates Full Year Fiscal 2026 Guidance, and Extends Long-Range Plan to 2029
May 6, 2026
 · 
35 min read
Press Releases
Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819
May 5, 2026
 · 
8 min read
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