FDA Approval Articles


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05/24/2018 07:24 AM


Samsung BioLogics Receives an additional FDA Approval for its world largest Plant's Production
PR Newswire (press release)
INCHEON, South Korea, May 24, 2018 /PRNewswire/ -- Samsung BioLogics announced today that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world's largest single ...

05/24/2018 05:06 AM


Allure Magazine

Restylane Lyft Is Now FDA-Approved For Use on Hands, Making It the First Legit Body Filler
Allure Magazine
Restylane, a hyaluronic acid filler, just received FDA approval for use on hands, making it the first injectable of its kind to receive FDA approval for use outside the face. Following a study of 89 patients, Restylane Lyft got the stamp of approval to ...

05/23/2018 09:32 PM


Zacks.com

Biotech Stock Roundup: FDA Gives Nod to Amgen's Drugs, EU Approves Exelixis' Cabometyx
Zacks.com
The Biotech space remained a key area of investors' focus with label expansion of a few prominent drugs and pipeline updates on a few others. While Amgen obtained the FDA approval for Prolia and Repatha, Exelixis also obtained approval for its lead ...

05/23/2018 06:29 PM


Investorplace.com

Avinger Inc Stock Goes Gangbusters on FDA Approval of Next-Gen Medical Device
Investorplace.com
Avinger Inc says that with the recent FDA approval, it is planning to immediately launch its two Pantheris Lumivascular devices in the U.S. It will also be adding these new designs to its INSIGHT IDE clinical trial. This trial is seeking to determine ...
Avinger Receives FDA Clearance of Next Generation Pantheris ...GlobeNewswire (press release)

all 17 news articles »

05/23/2018 06:20 PM


Scientific American

FDA Plans to Speed Path to Approval for Some Gene Therapies
Scientific American
The Food and Drug Administration will soon be alerting companies that certain gene therapies in development can qualify for less arduous review at the agency, Commissioner Scott Gottlieb said Tuesday. Specifically, gene therapies for hemophilia, a rare ...
"Right to try" bill passes, but will it help terminally ill patients?CBS News
"Right to Try" Bill Heads to President Trump for ApprovalRare Disease Report
Congress approves bill expanding access to experimental treatment for terminally ill patientsYahoo News
Wisconsin Public Radio News -Specialty Pharmacy Times
all 37 news articles »

05/23/2018 06:00 PM