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FDA

FDA
BioPharm Executive: The Rockville Files
Officially, there have been four new chemical entities have been approved since our last issue.
October 14, 2017
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1 min read
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Karl Thiel
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Amgen, Allergan Make History With First Cancer Biosimilar OK—Will Take on Genentech’s $6 Billion Best-Seller
September 15, 2017
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3 min read
Gecko Biomedical is Expanding Following Marketing Approval of its Vascular Sealant
FDA
Gecko Biomedical is Expanding Following Marketing Approval of its Vascular Sealant
September 12, 2017
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3 min read
Novartis to Hold On to Its 33% Stake in Roche—For Now
FDA
Novartis AG Waltzes to the Finish Line With First Ever FDA Approval for CAR-T
August 30, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Adamas Wins FDA OK for the First and Only Drug for Parkinson’s Dyskinesia Drug
August 25, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA
August 18, 2017
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
FDA Green Lights Pfizer Drug for Rare, Fast-Killing Type of Leukemia
August 18, 2017
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2 min read
FDA
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study
August 17, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
This is What Happens When the FDA Approves Cancer Drugs Too Quickly
August 17, 2017
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3 min read
AbbVie Leaps Into the Land of Oncolytics With New Turnstone Biologics Tie-Up
FDA
AbbVie Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C
August 4, 2017
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3 min read
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PRESS RELEASES
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
Press Releases
After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS
May 4, 2026
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7 min read
Press Releases
Applied BioCode Announces FDA Clearance for KingFisher™ Nucleic Acid Extraction with BioCode® Respiratory Pathogen Panel for IVD Use
May 4, 2026
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2 min read
Press Releases
ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older
May 4, 2026
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6 min read
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