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Approvals

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
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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
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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
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2 min read
FDA
President Elect Donald Trump And FDA
November 14, 2016
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1 min read
Antares Pharma Implodes After FDA Responds to Its Xyosted NDA
FDA
Bay Area’s Dynavax Plunges After the FDA Spurns HEPLISAV-B Again
November 14, 2016
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2 min read
5 Biopharma Influencers Likely to Be on Trump’s Transition Team
FDA
Trump Promises to “Reform the FDA” in Post-Election Mission Statement
November 11, 2016
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3 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
This Is Why Woodcock OKed Sarepta’s DMD Drug
November 4, 2016
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
FDA Slaps Partial Hold on Bay Area Firm Aduro Biotech’s Cancer Vaccine Trial
October 24, 2016
 · 
2 min read
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PRESS RELEASES
FDA
FDA Grants IND and Approves Clinical Trial Protocol of Inhaled Ampion for COVID-19 Patients with Respiratory Distress
September 21, 2020
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4 min read
FDA
EPA Approves PDI’s Super Sani-Cloth® Wipes for Use Against SARS-CoV-2
September 18, 2020
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2 min read
FDA
AlloVir Announces the FDA Clearance of Investigational New Drug Application (IND) for ALVR109 for the Treatment of High-Risk COVID-19 Patients
September 17, 2020
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4 min read
FDA
CytRx Highlights Orphazyme’s Receipt of FDA Acceptance and Priority Review of its New Drug Application for arimoclomol for Niemann-Pick disease Type C
September 17, 2020
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6 min read
Business
FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)
September 16, 2020
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5 min read
FDA
Vericel Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
September 16, 2020
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5 min read
FDA
MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
September 16, 2020
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9 min read
FDA
Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
September 15, 2020
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6 min read
FDA
GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle
September 15, 2020
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9 min read
FDA
Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa® (netarsudil ophthalmic solution) 0.02%
September 15, 2020
 · 
7 min read
FDA
Neurocrine Biosciences Announces Once-Daily ONGENTYS® (opicapone) Now Available in the U.S. as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes
September 14, 2020
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11 min read
FDA
US FDA Grants Once Daily Dosing Option for NITYR (nitisinone) Tablets for HT-1 Patients
September 14, 2020
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2 min read
FDA
ESSA Pharma Announces Fast Track Designation Granted by the FDA to EPI-7386 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
September 14, 2020
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6 min read
Drug Development
Biohaven’s Oral Zavegepant, A Third Generation CGRP Receptor Antagonist, Receives Authorization To Proceed From FDA And Achieves First In Human Dosing
September 10, 2020
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5 min read
FDA
FDA Approves Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Both Asthma and COPD in the US
September 9, 2020
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12 min read
FDA
Alydia Health Announces FDA Clearance and Publication of Pivotal Study of Innovative Treatment for Leading Cause of Maternal Injury and Death
September 9, 2020
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6 min read
FDA
APhA Hails HHS Announcement Authorizing Pharmacists to Administer COVID-19 Vaccines
September 9, 2020
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3 min read
FDA
Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation
September 9, 2020
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3 min read
FDA
Clarity Pharmaceuticals Announces the US FDA Grants Rare Paediatric Disease Designation to 64Cu-SARTATE™, a diagnostic for the clinical management of neuroblastoma
September 9, 2020
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3 min read
Drug Development
Aldeyra Receives Study May Proceed Letter from FDA to Initiate Clinical Trial of ADX-629 in COVID-19 Patients
September 9, 2020
 · 
7 min read
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