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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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