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Approvals

FDA
Forbes Under 30 Alumni Scores FDA Clearance For New Heart Monitor
June 7, 2017
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1 min read
How Much is Too Much to Pay for Newly Approved Drugs?
FDA
How Much is Too Much to Pay for Newly Approved Drugs?
June 6, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Market Just Got More Crowded as Regeneron, Sanofi’s New RA Drug Wins FDA Approval
May 23, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Merck & Co.'s Immuno-Oncology Star Racks Up Two New Bladder Cancer Approvals
May 19, 2017
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3 min read
FDA
Faster FDA Approvals? Not So Fast: 1 Out of 3 New Drugs Had Safety Problems No One Knew About
May 10, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years
May 8, 2017
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2 min read
AstraZeneca PLC Offloads Remaining Anesthetics Portfolio in $766 Million Deal
FDA
AstraZeneca PLC Hits Milestone With Approval of Potential Bladder Cancer Blockbuster
May 2, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Takeda’s $5 Billion Bet on Ariad Pays Off With Accelerated Approval of Lung Cancer Med
May 1, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Wowsers! FDA Approves BioMarin’s Brineura, the First Drug for Batten Disease
April 28, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Just Rejected Eli Lilly, Incyte’s Rheumatoid Arthritis Drug Baricitinib
April 14, 2017
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2 min read
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PRESS RELEASES
FDA
ARCA biopharma Announces FDA Approval of IND Application for AB201 as a Potential Treatment for COVID-19
October 7, 2020
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7 min read
FDA
First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services’ AJIPHASE Technology Receives FDA Approval
October 6, 2020
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2 min read
FDA
Biosense Webster Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation
October 6, 2020
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9 min read
FDA
Aegle Therapeutics Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for AGLE-102 for Patients with Dystrophic Epidermolysis Bullosa
October 6, 2020
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2 min read
FDA
FDA Broadly Supports Oragenics’ Pre-IND Development Program for its SARS-CoV-2 Vaccine
October 6, 2020
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4 min read
FDA
Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection
October 6, 2020
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3 min read
FDA
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
October 2, 2020
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38 min read
FDA
FDA Approves Drug Combination for Treating Mesothelioma
October 2, 2020
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3 min read
FDA
BioMarin, Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307
October 2, 2020
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9 min read
FDA
Dascena Receives FDA EUA for COVID-19 Hemodynamic Instability and Respiratory Decompensation Prediction System
October 2, 2020
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3 min read
FDA
Teva Launches First Generic Versions of HIV-1 Treatments TRUVADA® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets in the U.S.
October 2, 2020
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27 min read
FDA
Endo Begins Shipment of Generic Kuvan® Tablets and Powder for Oral Solution (sapropterin dihydrochloride)
October 1, 2020
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3 min read
FDA
SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications
October 1, 2020
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3 min read
FDA
Food and Drug Administration Renews and Expands Use of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
October 1, 2020
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3 min read
FDA
FDA Grants Fast Track Status to Aegle Therapeutics’ AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa
October 1, 2020
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1 min read
FDA
Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study
October 1, 2020
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6 min read
FDA
American Regent Introduces Tralement™ (trace elements injection 4*, USP)
September 30, 2020
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8 min read
FDA
SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
September 30, 2020
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14 min read
FDA
Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency
September 29, 2020
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8 min read
FDA
Adial Pharmaceuticals Announces COVID-19 Point-of-Care Antibody Test Granted First Ever FDA Emergency Use Authorization for Use with Fingerstick Blood Samples
September 29, 2020
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6 min read
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