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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
Restylane Lyft Is Now FDA-Approved For Use on Hands, Making It the First Legit Body Filler
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
Biotech Stock Roundup: FDA Gives Nod to Amgen's Drugs, EU Approves Exelixis' Cabometyx
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
Avinger Inc Stock Goes Gangbusters on FDA Approval of Next-Gen Medical Device
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 ...
05/23/2018 06:20 PM
FDA Plans to Speed Path to Approval for Some Gene Therapies
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?
"Right to Try" Bill Heads to President Trump for Approval
Congress approves bill expanding access to experimental treatment for terminally ill patients
05/23/2018 06:00 PM