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Approvals

FDA
FDA OKs Topcon’s Ocular Diagnostic Instrument
Topcon’s touted its system as being able to quickly penetrate ocular tissues without being obscured by hemorrhage or media opacities.
January 23, 2018
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1 min read
FDA
Following FDA Approval for PAD, Ra Medical Steps Up Hiring
Ra Medical only has five full-time salespeople on staff, but expects that to grow to 20 to 25 people later this year.
January 15, 2018
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3 min read
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Alex Keown
FDA
PTC Therapeutics CEO to Fight for DMD Therapy, Pushes Forward with SMA Treatment
The company believes the Translarna data is compelling and pointed to the success the drug is having in Europe.
January 10, 2018
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3 min read
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Alex Keown
FDA
Will 2018 Be Another Record Year for FDA Approvals?
2017 was the second-best year for FDA approvals since 1996.
January 8, 2018
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1 min read
FDA
FDA Approves New Type 2 Diabetes Drug From Merck, Pfizer
The FDA approved Merck’s and Pfizer’s Steglatro, a SGLT2-inhibitor, that will square off against established drugs in the market.
December 21, 2017
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2 min read
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Alex Keown
FDA
Spark Gets FDA Greenlight for Luxturna, The First Gene Therapy for Eye Disease Approved in the U.S.
The FDA broke new ground today with a first-of-its-kind therapy for eye disease.
December 19, 2017
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3 min read
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Alex Keown
FDA
Aerie’s Glaucoma Drug Scores Early FDA Approval
Christmas came a week early for Aerie Pharmaceuticals.
December 18, 2017
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2 min read
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Alex Keown
FDA
Karolinska Development’s Portfolio Company Promimic Receives FDA Approval for HAnano Surface for Use on Dental Implants
The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices.
December 14, 2017
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1 min read
FDA
FDA Acknowledges That Mediocre Is Sometimes All We Have
A look at the latest batch of FDA approvals this year.
December 12, 2017
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1 min read
FDA
Why a FDA Approval for an Accessory Could be a Huge Deal for Apple
This could be the first step in a long journey that could amount to huge profitability for the iPhone maker.
December 11, 2017
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1 min read
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PRESS RELEASES
FDA
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
November 19, 2020
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3 min read
FDA
Armis Biopharma Announces FDA Approval of VeriFixx™ Small Bone Implant
November 19, 2020
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2 min read
FDA
Orchard Therapeutics Announces FDA Clearance of IND Application for OTL-200 for Metachromatic Leukodystrophy (MLD)
November 19, 2020
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7 min read
FDA
Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature
November 18, 2020
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7 min read
FDA
QBiotics’ STELFONTA® Receives FDA Approval for Canine Mast cell Tumours
November 18, 2020
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3 min read
FDA
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
November 17, 2020
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3 min read
FDA
ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention
November 17, 2020
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6 min read
FDA
Sommetrics Receives FDA Breakthrough Device Designation for Its aerSleep II Product to Treat Sleep Apnea
November 17, 2020
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2 min read
FDA
TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant
November 17, 2020
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3 min read
Drug Development
RedHill Biopharma’s Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease
November 17, 2020
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9 min read
FDA
UCB’s VIMPAT® (lacosamide) CV now approved by FDA for primary generalized tonic-clonic seizures and expanded pediatric use for people living with epilepsy
November 17, 2020
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16 min read
FDA
FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
November 16, 2020
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4 min read
FDA
Amylyx Pharmaceuticals Announces FDA Granted Orphan Drug Designation for AMX0035 for the Treatment of Wolfram Syndrome
November 16, 2020
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3 min read
FDA
Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis
November 16, 2020
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8 min read
FDA
Dicerna Announces FDA Acceptance of Lilly’s Investigational New Drug (IND) Application for First GalXC™ RNAi Candidate Under Companies’ Global Research Collaboration and Licensing Agreement
November 16, 2020
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6 min read
Drug Development
INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense
November 16, 2020
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12 min read
FDA
Agilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer
November 13, 2020
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3 min read
FDA
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)
November 13, 2020
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42 min read
FDA
Agios Announces FDA Orphan Drug Designation Granted to Mitapivat for Treatment of Sickle Cell Disease
November 12, 2020
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6 min read
FDA
New FDA Cleared Automated Ear Cleaning Device Brings Ear Care Into the 21st Century
November 12, 2020
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2 min read
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