FDA Approval Articles


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07/18/2018 12:00 AM


Mass Device

Avenger receives FDA approval for Pantheris altherectomy device
Mass Device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and ...

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07/17/2018 09:30 PM


Diagnostic and Interventional Cardiology (press release) (blog)

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Diagnostic and Interventional Cardiology (press release) (blog)
July 17, 2018 — Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System ...

07/17/2018 06:53 PM


CNN

Are 'breakthrough' drugs as safe as other FDA-approved medicines?
CNN
(CNN) New research questions the quality of drugs given the "breakthrough therapy" designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental ...

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07/17/2018 04:08 PM


Rockwell receives FDA approval to begin manufacturing Calcitriol
Healio
Rockwell Medical Inc. reported that it has received FDA approval to begin manufacturing Calcitriol, the company's active vitamin D injection for the management of hypocalcemia in patients undergoing chronic hemodialysis. In a press release, Rockwell ...

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07/17/2018 03:04 PM


FierceBiotech

In a first, FDA approves SIGA's smallpox treatment
FierceBiotech
The FDA has approved the first treatment for smallpox. SIGA Technologies tested the drug in 359 healthy volunteers to demonstrate safety and relied on animal data to show efficacy. Smallpox was eradicated in 1980, but the presence of the virus in ...
The FDA just approved a drug to treat smallpox in case of a bioterrorism attack — here's why that scenario is so scaryBusiness Insider
FDA approves drug for smallpox nearly 40 years after disease was eradicated — here's whyGlobalnews.ca
Why The FDA Just Approved A Drug For Smallpox, A Disease That ...HuffPost
In-PharmaTechnologist.com -Equities.com -FDA.gov
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07/17/2018 01:59 PM