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FDA

FDA
Why Newron Pharma’s Newly Approved Parkinson’s Drug Isn’t All That Novel
March 23, 2017
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1 min read
AstraZeneca PLC Offloads Remaining Anesthetics Portfolio in $766 Million Deal
FDA
FDA Deals Another Blow to AstraZeneca PLC’s Blood Drug
March 17, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Sarepta Under Pressure As Marathon Pharma Emflaza’s Wins FDA Approval for DMD
February 10, 2017
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3 min read
Genentech Grows on Promise of 70+ Drug Approvals
FDA
Genentech’s $94,000-a-Year Drug Tarceva: Why Faster FDA Approvals Could Backfire
February 7, 2017
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4 min read
Investors Sigh With Relief as Biogen's Alzheimer's Drug Delivers in Early-Stage Study
Drug Development
New Spinraza Data Has Biogen Screaming ‘It’s Worth It!’
January 13, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Tesaro Craters as the FDA Denies Approval of Rolapitant IV
January 12, 2017
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Approval of Aurobindo’s Two Drugs Sends Stock Up
December 30, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Approves First-Ever Treatment for Spinal Muscular Atrophy; Ionis Pharma, Biogen Seal Victory
December 27, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
Latest Deaths in Juno Trial Puts Unwanted Limelight on the FDA
November 28, 2016
 · 
2 min read
FDA
President Elect Donald Trump And FDA
November 14, 2016
 · 
1 min read
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PRESS RELEASES
Press Releases
Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial
May 7, 2026
 · 
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
 · 
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
 · 
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
Press Releases
Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)
May 5, 2026
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8 min read
Press Releases
Opus Genetics Announces FDA Acceptance of OPGx-LCA5 into Rare Disease Evidence Principles (RDEP) Program
May 4, 2026
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5 min read
Press Releases
Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA Approval of LANGLARA™ an Interchangeable Biosimilar of Lantus® (insulin glargine)
May 4, 2026
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5 min read
Press Releases
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen for McCune-Albright Syndrome
May 4, 2026
 · 
7 min read
Press Releases
Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies
May 4, 2026
 · 
6 min read
Press Releases
NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA
May 4, 2026
 · 
9 min read
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