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RSS FeedPosted by Michael Wonder on 10 Aug 2020
Gilead submits new drug application to U.S. Food and Drug Administration for Veklury (remdesivir) for the treatment of COVID-19
10 August 2020 - Veklury is currently available in the U.S. for the treatment of severe COVID-19 under an Emergency Use ...
Posted by Michael Wonder on 10 Aug 2020
Aquestive Therapeutics receives FDA fast track designation for AQST-108 (sublingual film formulation delivering systemic epinephrine) for treatment of allergic reactions including anaphylaxis
10 August 2020 - Finalising preparations for pharmacokinetic clinical trials of AQST-108. ...
Posted by Michael Wonder on 10 Aug 2020
Mallinckrodt announces U.S. FDA filing acceptance of biologics license application for StrataGraft regenerative skin tissue for treatment of adults with deep partial-thickness thermal burns
10 August 2020 - StrataGraft skin tissue, if approved, could reduce or eliminate the need for auto-grafting of healthy skin to ...
Posted by Michael Wonder on 10 Aug 2020
ICER to assess treatments for lupus nephritis
10 August 2020 - Report will be subject of New England CEPAC meeting in March 2021; Open Input now being accepted ...
Posted by Michael Wonder on 10 Aug 2020
Stephen Hahn MD, FDA chief, is caught between scientists and the President
10 August 2020 - Many medical experts - including members of his own staff - worry about whether Dr Hahn ...
Posted by Michael Wonder on 09 Aug 2020
Ensuring access to emerging COVID-19 treatments through Medicare reimbursement policy
7 August 2020 - Effective pharmaceutical treatments for coronavirus disease 2019 (COVID-19) are urgently needed, and there has been an explosion ...
Posted by Michael Wonder on 08 Aug 2020
U.S. Food and Drug Administration approves Lampit (nifurtimox) for the treatment of Chagas disease in children
7 August 2020 - Only Chagas disease treatment approved in U.S. for use in children from birth to less than 18 ...
Posted by Michael Wonder on 08 Aug 2020
FDA approves new opioid for intravenous use in hospitals, other controlled clinical settings
7 August 2020 - Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management ...
Posted by Michael Wonder on 07 Aug 2020
FDA accepts Biogen's aducanumab biologics license application for Alzheimer's disease with priority review
7 August 2020 - If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease. ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves first liquid biopsy next generation sequencing companion diagnostic test
7 August 2020 - Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses ...
Posted by Michael Wonder on 07 Aug 2020
Unwavering regulatory safeguards for COVID-19 vaccines
7 August 2020 - The coronavirus disease 2019 (COVID-19) pandemic has disrupted normal life and had significant consequences for human health, ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves oral treatment for spinal muscular atrophy
7 August 2020 - The U.S. Food and Drug Administration today approved Evrysdi (risdiplam) to treat patients two months of age ...
Posted by Michael Wonder on 07 Aug 2020
Y-mAbs announces completion of submission of omburtamab biologics license application to FDA
6 August 2020 - Y-mAbs Therapeutics today announced that on 5 August 2020, the Company completed the submission of its biologics ...
Posted by Michael Wonder on 07 Aug 2020
ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1
August 2020 - ViiV Healthcare today announced that the US FDA approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment ...
Posted by Michael Wonder on 06 Aug 2020
Trump signs executive order requiring government to buy ‘essential’ drugs from U.S. companies
6 August 2020 - The president is expected to sign the order during his trip to Ohio later Thursday, White House ...