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FDA

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Therapy Status To Takeda Pharmaceutical Co. Ltd.'s Ixazomib
December 5, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Speedy FDA Approval For Amgen’s Leukemia Immunotherapy BLINCYTO
December 4, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
National Institute for Clinical Excellence (NICE) Reverses October Decision And Approves Roche’s Oncology Drug Gazyvaro
December 2, 2014
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
Drug Development
FDA Requires Additional Data On Bristol-Myers Squibb Company’ Hep C Daclatasvir
November 26, 2014
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1 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
France Strikes Deal For Gilead Sciences, Inc.'s Hep C Drug Sovaldi
November 21, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Purdue Pharma L.P. Wins FDA Approval For Powerful Painkiller Hysingla
November 20, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Regeneron, ReGen Therapeutics Plc Eczema Drug Dupilumab Gets FDA Breakthrough Therapy Designation
November 20, 2014
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2 min read
Mylan Inc., Theravance, Inc. Partner Up for $265 Million COPD Pact
FDA
Regeneron’s Eylea Gets Japanese Nod For Macular Edema
November 18, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Lemtrada For MS
November 17, 2014
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2 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Eli Lilly Wins FDA Approval For Gastric Cancer Combination Drug
November 6, 2014
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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
 · 
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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