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Approvals

FDA
China Approves Tianjin CanSino’s Ebola Vaccine
Tianjin CanSino Biologics announced CFDA approval of its Ebola virus vaccine for China.
October 25, 2017
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1 min read
FDA
Alexion Wins Expanded Approval for Blockbuster Drug Soliris
Alexion is set to secure even more revenue from its blockbuster drug Soliris, the most expensive drug in the world.
October 23, 2017
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3 min read
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Alex Keown
FDA
Second CAR-T Approval Points to Exciting Times for Gene Therapy
Big pharmas are having a good year so far in terms of FDA approvals.
October 23, 2017
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1 min read
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Karl Thiel
Novartis Has Set a Tricky Precedent in Gene Therap
FDA
Novartis Has Set a Tricky Precedent in Gene Therapy
A look at how the gene therapy approvals may end up confusing payers, lawmakers, and the general public at a time when the industry desperately needs clarity.
October 19, 2017
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5 min read
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Karl Thiel
A Novo Nordisk flag flies in the wind/Courtesy jor
FDA
Eli Lilly Looks Over Its Shoulder After Novo Nordisk Wins FDA Panel Backing for Diabetes Drug
An advisory panel with the FDA gave a near unanimous support to Novo Nordisk’s diabetes drug semaglutide, a long-acting GLP-1 analogue.
October 19, 2017
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2 min read
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Alex Keown
Gilead's $12B Bet Pays Off in Two Months After the
FDA
Gilead’s $12B Bet Pays Off in Two Months After the FDA Approves Kite’s Revolutionary CAR-T Therapy
Maybe timing is everything. On Aug. 28, 2017, Gilead acquired Kite for about $11.9B.
October 18, 2017
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3 min read
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Mark Terry
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
 · 
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
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PRESS RELEASES
Drug Development
Insignis Therapeutics and HLK Pharmacin Receive FDA IND Clearance to Initiate a Phase 1 Trial With IN-001 for Oral Anaphylaxis Treatment
October 29, 2020
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3 min read
FDA
reVision Therapeutics Announces US FDA Grant of Rare Pediatric Disease and Orphan-Drug Designation for REV-0100 for the Treatment of Stargardt Disease
October 28, 2020
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3 min read
FDA
FDA Approves Lotion for Nonprescription Use to Treat Head Lice
October 27, 2020
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3 min read
FDA
FDA Approves New FoundationOne®Liquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and Non-Small Cell Lung Cancer
October 27, 2020
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6 min read
FDA
Kala Pharmaceuticals Announces FDA Approval of EYSUVIS™ for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
October 27, 2020
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10 min read
FDA
Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VSJ-110 for Allergic Conjunctivitis
October 26, 2020
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6 min read
FDA
Medtronic Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction
October 26, 2020
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5 min read
FDA
Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications
October 26, 2020
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5 min read
FDA
Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve
October 26, 2020
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2 min read
FDA
FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology
October 26, 2020
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7 min read
FDA
SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission
October 26, 2020
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8 min read
FDA
Jazz Pharmaceuticals Acquires SpringWorks Therapeutics’ FAAH Inhibitor Program
October 26, 2020
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9 min read
FDA
FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI®(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid Tumors
October 23, 2020
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5 min read
FDA
FDA Approves FoundationOne®CDx as Companion Diagnostic for Vitrakvi® (larotrectinib), to Aid in Identifying NTRK Fusion-Positive Patients
October 23, 2020
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8 min read
FDA
Ligand’s Captisol Technology Plays Key Role in the Manufacture of Gilead’s Veklury, the First FDA-Approved COVID-19 Treatment
October 23, 2020
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8 min read
FDA
GI Supply Gets FDA Clearance for its Submucosal Lifting Agent in a Second Size, a Pre-filled 10mL Syringe
October 23, 2020
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2 min read
FDA
FDA Approves First Treatment for COVID-19
October 22, 2020
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5 min read
FDA
U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19
October 22, 2020
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13 min read
FDA
Adaptive Phage Therapeutics Receives Orphan Drug Designation for PhageBank™ in Prosthetic Joint Infections
October 22, 2020
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3 min read
FDA
Avioq Announces FDA Approval of VioOne™ HIV Profile™ Supplemental Assay
October 22, 2020
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1 min read
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