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FDA

FDA
Betting Intensifies Over Sarepta’s DMD Drug
May 6, 2016
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Sarepta Craters as the FDA Releases Documents Ahead of Monday’s DMD Drug Hearing
April 21, 2016
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
36 DMD Experts Send Letter to the FDA Urging Approval of Sarepta’s Drug
March 22, 2016
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Roche’s Multiple Sclerosis Drug Gets Breakthrough Status, Likely to Haunt Biogen
February 17, 2016
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AstraZeneca PLC Continues Its Immuno-Oncology Roll, Durvalumab Gets Breathrough Designation for Bladder Cancer
February 17, 2016
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves AVANIR New Migraine Treatment With Unique Inhalant Delivery System
January 29, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January
December 22, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Investors Elated as Amgen Wins FDA Approval for First-of-Its-Kind Cancer Killing Virus Drug
October 28, 2015
 · 
3 min read
Drug Development
FDA Designates Pfizer’s Acute Lymphoblastic Leukemia Drug Breakthrough Status
October 19, 2015
 · 
7 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
As Spinoff Rumors Spin, Sanofi’s Cholesterol Drug Praluent Gets Approval in Europe
September 28, 2015
 · 
3 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
 · 
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
 · 
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
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
 · 
6 min read
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