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FDA

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Purdue Pharma L.P.’s Hard-to-Abuse Narcotic Painkiller
July 28, 2014
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2 min read
FDA
First Remote-Control Leg Lengthening Implant Cleared by the FDA, Sinai Hospital Reveals
February 8, 2012
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1 min read
FDA
FDA Told To Reconsider Barr Pharmaceuticals, Inc.'s Morning-After Pill Access
March 24, 2009
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1 min read
FDA
CBER: Substantially Equivalent 510(k) Device Information for CaridianBCT, Inc.
October 22, 2008
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1 min read
FDA
FDA Delays: Hurry Up and Wait
September 23, 2008
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1 min read
FDA
Industry Goes on Offense on Medical Device Approvals, AdvaMed
September 5, 2008
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1 min read
FDA
FDA Clears Test to Help Doctors Manage Heart Transplant Patients
August 27, 2008
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1 min read
FDA
FDA On Pace To Approve 18 New Drugs In 2008
August 8, 2008
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1 min read
FDA
FDA Approves 2008-2009 Season’s Flu Vaccines: CSL Limited, Afluria. GlaxoSmithKline Biologicals, Fluarix. ID Biomedical Corporation of Quebec, FluLaval. MedImmune Vaccines, FluMist. Novartis Vaccines & Diagnostics, Inc., Fluvirin. Sanofi Pasteur, Fluzone.
August 6, 2008
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1 min read
FDA
CDRH Updates:: Invitrogen Corporation SPOT-Light(R) HER2 CISH(TM) Kit - P050040 Approval
August 1, 2008
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1 min read
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PRESS RELEASES
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
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4 min read
Press Releases
Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor
May 7, 2026
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4 min read
Press Releases
Mezzion Reports Pre-IND FDA Feedback on the Development of Udenafil in ADPKD
May 7, 2026
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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
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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
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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
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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
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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
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3 min read
Press Releases
Sight Sciences Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Revenue Guidance
May 7, 2026
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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
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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
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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
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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
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35 min read
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