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FDA

With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
FDA
With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
July 28, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co.'s C. Diff Drug, New PDUFA Date Set
July 22, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Opko Health Rockets on FDA Approval of Rayaldee Four Months Ahead of PDUFA Date
June 21, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Shire Nabs Breakthrough Tags for Drug to Treat Rare Gastrointestinal Conditions
June 13, 2016
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
Pfizer Quietly Raised Drug Prices By an Average of 8.8% Last Week
June 10, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Questions Merck & Co.'s C. Diff Diarrhea Medication’s Efficacy
June 8, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Biogen and AbbVie’s Once-Monthly MS Drug Zinbryta
May 31, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Titan Pharma Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency
May 27, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Genentech Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years
May 18, 2016
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3 min read
FDA
Chiasma Chief Says Firm May Challenge FDA Over Rare-Disease Drug Rejection
May 12, 2016
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2 min read
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PRESS RELEASES
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
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
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8 min read
Press Releases
FDA Grants Fast Track Designation for CS-1103, a First-in-class Small Molecule to Reverse Acute Intoxication from Fentanyl
May 5, 2026
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2 min read
Press Releases
Nanobiotix Announces Protocol Amendment to Ongoing Global Phase 3 Head and Neck Cancer Study
May 5, 2026
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6 min read
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