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RSS FeedPosted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 21 Jun 2021
Factors associated with generic drug uptake in the United States, 2012 to 2017
19 June 2021 - In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower cost generics ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...
Posted by Michael Wonder on 20 Jun 2021
United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19
18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...
Posted by Michael Wonder on 18 Jun 2021
The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis
18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...
Posted by Michael Wonder on 18 Jun 2021
Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug
18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...
Posted by Michael Wonder on 18 Jun 2021
Manchin wants Biden to oust FDA Chief over controversial Alzheimer’s drug approval
17 June 2021 - After some of the FDA’s outside advisors quit in outrage after the agency approved a controversial new ...
Posted by Michael Wonder on 18 Jun 2021
Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
18 June 2021 - Orphazyme today announced it has received a complete response letter from the U.S. FDA following its ...
Posted by Michael Wonder on 17 Jun 2021
Furore rages over FDA approval of controversial Alzheimer’s drug
17 June 2021 - Critics attack the agency’s action as reckless, but defenders say patients will benefit. ...
Posted by Michael Wonder on 17 Jun 2021
The FDA is in desperate need of some soul-searching
17 June 2021 - Ordinarily, the approval of a new drug for a dreaded disease affecting millions of Americans would be ...
Posted by Michael Wonder on 17 Jun 2021
Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab
17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...
Posted by Michael Wonder on 17 Jun 2021
Agenus announces U.S. FDA acceptance and priority review of balstilimab biologics license application for the treatment of recurrent or metastatic cervical cancer
17 June 2021 - Agenus today announced that the U.S. FDA has accepted Agenus’ biologics license application for balstilimab, an ...
Posted by Michael Wonder on 17 Jun 2021
FDA approves a nasal anti-histamine for non-prescription use
17 June 2021 - The U.S. FDA today approved a nasal antihistamine for nonprescription use through a process called a partial ...
Posted by Michael Wonder on 17 Jun 2021
Applied Therapeutics granted fast track designation by FDA for AT-007 for galactosaemia
17 June 2021 - Applied Therapeutics today announced that the U.S. FDA has granted fast track designation to AT-007 for the ...