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FDA

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Advisory Panel Votes Against Approval Of Johnson & Johnson’s Sirukumab
August 3, 2017
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2 min read
FDA
Blood Markers Of Chronic Fatigue Syndrome Could Pave The Way To A Diagnostic Test, Stanford Reveals
August 2, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Agios, Celgene Win Early FDA Approval for New Cancer Drug
August 1, 2017
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2 min read
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
FDA
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
August 1, 2017
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2 min read
Gilead Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
FDA
FDA Green Lights Gilead’s Vosevi, With a Black Box Warning Attached
July 19, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Puma Biotech Surges After the FDA Officially Approves Breast Cancer Drug
July 18, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Gives Nod to Johnson & Johnson’s Potential Blockbuster Psoriasis Med
July 14, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Panel Unanimously Endorses Novartis AG’s CAR-T Leukemia Drug
July 13, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Little-Known Emmaus Just Won Approval for First New Sickle Cell Drug in 20 Years
July 10, 2017
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2 min read
FDA
Here’s What The Latest Thermo Fisher Scientific Really Means And Why It’s So Important
June 28, 2017
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1 min read
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PRESS RELEASES
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
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
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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
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6 min read
Press Releases
NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA
May 4, 2026
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9 min read
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations
May 4, 2026
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4 min read
Press Releases
Satellite Bio Announces FDA Rare Pediatric Disease Designation for SB-101 for the Treatment of Urea Cycle Disorders (UCDs)
May 4, 2026
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3 min read
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