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. ...

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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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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 ...

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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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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 ...

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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 ...

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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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The world is spending nowhere near enough on a coronavirus vaccine

6 August 2020 - Far better to spend far too much. ...

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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 ...

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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. ...

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