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Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Nothing’s Gonna Stop Neurocrine Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults
April 12, 2017
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3 min read
FDA
Gilead Release: FDA Approves New Indications For Harvoni And Sovaldi In Pediatric Patients 12 Years And Older With Chronic Hepatitis C Infection
April 7, 2017
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10 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases
April 6, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Teva Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo
April 4, 2017
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2 min read
What a Day! Genentech Lands FDA Approval for First Drug to Treat Severe Multiple Sclerosis
FDA
What a Day! Genentech Lands FDA Approval for First Drug to Treat Severe Multiple Sclerosis
March 29, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Clears Massachusetts Biotech Tesaro’s Ovarian Cancer PARP Inhibitor
March 27, 2017
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3 min read
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
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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
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PRESS RELEASES
FDA
Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC
September 29, 2020
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6 min read
FDA
FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin™
September 29, 2020
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4 min read
FDA
U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
September 28, 2020
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21 min read
FDA
U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
September 28, 2020
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8 min read
FDA
Shionogi Announces FDA Approval of FETROJA® (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
September 28, 2020
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13 min read
FDA
Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay
September 28, 2020
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4 min read
FDA
Masimo Announces FDA Clearance of the Rad-G™ Pulse Oximeter
September 28, 2020
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9 min read
FDA
AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
September 28, 2020
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9 min read
FDA
FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
September 25, 2020
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3 min read
FDA
FDA Approves Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
September 25, 2020
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8 min read
FDA
FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
September 25, 2020
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7 min read
FDA
FDA Approves Bausch + Lomb Alaway® Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%
September 25, 2020
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5 min read
FDA
Neurophth Therapeutics’ Treatment of Leber’s Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by U.S. FDA
September 24, 2020
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7 min read
FDA
Innova Therapeutics Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for IVT-8086 for the Treatment of Osteosarcoma
September 24, 2020
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3 min read
FDA
Surmodics Receives FDA 510(k) Clearance for Pounce™ Thrombus Retrieval System
September 23, 2020
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5 min read
FDA
Baxter Announces U.S. FDA Approval of Clinimix and Clinimix E with Higher Protein for Patients Requiring Parenteral Nutrition
September 23, 2020
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11 min read
FDA
Life Spine Announces FDA 510(k) Clearance for SI Joint Revision Offering and Additional Claims for the SImpact® Sacroiliac Joint Fixation System
September 22, 2020
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2 min read
Drug Development
Genocea Announces FDA Acceptance of GEN-011 IND ApplicationNovel adoptive T cell therapy targets checkpoint-refractory solid tumors with neoantigen-specific T cells from peripheral blood
September 22, 2020
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2 min read
FDA
Medeor Therapeutics’ Transplant Immune Tolerance Therapy Receives Regenerative Medicine Advanced Therapy Designation from FDA
September 22, 2020
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2 min read
FDA
Spineology® Announces FDA De Novo Grant of Minimally Invasive OptiMesh® Expandable Interbody Fusion System
September 21, 2020
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3 min read
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