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Approvals

FDA
Onyx’s Setback. Why We Still Like The Stock
October 19, 2005
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1 min read
FDA
Johnson & Johnson Gains On FDA Approval Of Disk
October 19, 2005
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1 min read
FDA
Amgen Gets EU Approval For Mimpara
October 19, 2005
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1 min read
FDA
Biotech Investors: Mark Your 2005 Calendars
October 19, 2005
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1 min read
FDA
FDA Approves Use Of Chip In Patients
October 19, 2005
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1 min read
FDA
FDA OKs Generic Antidotes For Anthrax
October 19, 2005
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1 min read
FDA
FDA OKs Defibrillator Without Prescription
October 19, 2005
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1 min read
FDA
First OTC Cholesterol Drug Launched In Britain
October 19, 2005
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1 min read
FDA
UK’s Profile Therapeutics Inhaler Approved In U.S.
October 19, 2005
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1 min read
FDA
Waiter, There’s A Drug In My Rice; California’s First Crop Genetically Modified To Contain A Drug
October 19, 2005
 · 
1 min read
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PRESS RELEASES
Business
AmerisourceBergen Selected by Deciphera Pharmaceuticals to Support QINLOCK™
May 26, 2020
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5 min read
Drug Development
Protara Therapeutics Receives Fast Track Designation from U.S. FDA for Intravenous Choline Chloride for the Treatment of Intestinal Failure Associated Liver Disease
May 26, 2020
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4 min read
FDA
Alnylam Announces U.S. Food and Drug Administration Has Granted Priority Review of the Lumasiran New Drug Application for the Treatment of Primary Hyperoxaluria Type 1
May 26, 2020
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9 min read
FDA
U.S. FDA Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer
May 22, 2020
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21 min read
FDA
U.S. FDA Approves Evofem Biosciences’ Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
May 22, 2020
 · 
6 min read
FDA
Medtronic Guardian™ Connect Continuous Glucose Monitoring (CGM) System for Diabetes Now Compatible with Android Devices
May 22, 2020
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4 min read
FDA
Second Parkinson’s Therapy Funded by The Michael J. Fox Foundation Receives FDA Approval and Advances to Market
May 22, 2020
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4 min read
FDA
Mayne Pharma launches BAC 300 capsules in the United States
May 22, 2020
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2 min read
FDA
Sunovion Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes
May 21, 2020
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12 min read
FDA
Chiesi Group Receives FDA Approval for Ferriprox® (deferiprone) twice-a-day tablets
May 21, 2020
 · 
5 min read
FDA
Passage Bio Receives Rare Pediatric Disease Designation for PBGM01 for Patients with GM1 Gangliosidosis– PBGM01 to enter the clinic in fourth quarter of 2020 –
May 21, 2020
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6 min read
FDA
FDA Approves Emergency Use of A&R Tarpaulins’ Patient Isolation Transportation Unit (PITU)
May 20, 2020
 · 
2 min read
Drug Development
FDA Approves Octapharma USA Investigational New Drug Application for Severe COVID-19 Patients
May 20, 2020
 · 
5 min read
FDA
Evoke Receives FDA Conditional Acceptance of Gimoti Brand Name Following NDA Resubmission
May 20, 2020
 · 
4 min read
FDA
Foundation Medicine Receives FDA Approval for FoundationOne®CDx as the Companion Diagnostic for LYNPARZA® to Identify Patients with HRR-Mutated Metastatic Castration-Resistant Prostate Cancer
May 20, 2020
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4 min read
FDA
LYNPARZA® (Olaparib) Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
May 20, 2020
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22 min read
FDA
Myriad Receives FDA Approval of BRACAnalysis CDx® as a Companion Diagnostic for Lynparza® in HRR-mutated Metastatic Castration-Resistant Prostate Cancer
May 20, 2020
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8 min read
FDA
LYNPARZA® (olaparib) Approved by FDA for Treatment of HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer That Has Progressed Following Prior Treatment with Enzalutamide or Abiraterone
May 20, 2020
 · 
24 min read
FDA
Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation
May 19, 2020
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4 min read
Business
St. Elizabeth Healthcare Partners with CTI and Pulmotect Becoming First Hospital Site for Phase-2 Clinical Trial Targeting COVID-19
May 19, 2020
 · 
3 min read
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