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RSS FeedPosted by Michael Wonder on 08 Aug 2020
Hard questions as scientists and governments seek COVID-19 vaccines
8 August 2020 - They must work out how much to invest, and how best to distribute the goods. ...
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
Novartis receives EC approval for new Xolair indication to treat severe chronic rhinosinusitis with nasal polyps
6 August 2020 - EC approves Xolair (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first ...
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
US FDA grants rare paediatric disease designation to paxalisib for DIPG
7 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 07 Aug 2020
Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) receives marketing approval in Canada for patients with LEMS
6 August 2020 - Catalyst Pharmaceuticals today announced that Canada’s national health care regulatory agency, Health Canada, has approved the ...
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
The world is spending nowhere near enough on a coronavirus vaccine
6 August 2020 - Far better to spend far too much. ...
Posted by Michael Wonder on 06 Aug 2020
Health experts to FDA: make your vaccine deliberations public
5 August 2020 - A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel ...
Posted by Michael Wonder on 06 Aug 2020
FDA approves GSK’s Blenrep (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma
6 August 2020 - Blenrep is the fifth major medicine approval for GSK in 2020. ...