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RSS FeedPosted by Michael Wonder on 11 Aug 2020
Mersana Therapeutics receives FDA fast track designation for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer
11 August 2020 - Mersana Therapeutics today announced that the U.S. FDA has granted fast track designation for XMT-1536, for the ...
Posted by Michael Wonder on 11 Aug 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce U.S. FDA acceptance of biologics license application for pegunigalsidase alfa for the proposed treatment of Fabry disease and grants priority review
11 August 2020 - Protalix BioTherapeutics together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, ...
Posted by Michael Wonder on 11 Aug 2020
Fennec Pharmaceuticals receives complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
11 August 2020 - FDA pre-approval inspection has identified deficiencies with the facility of the drug product manufacturer, which require resolution ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 11 Aug 2020
Alkindi approved in Australia
10 August 2020 - Diurnal Group announces that Alkindi (hydrocortisone granules in capsules for opening) has been approved by the ...
Posted 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
Communication@EMA
10 August 2020 - The European Medicines Agency has launched its third communication perception survey. ...
Posted by Michael Wonder on 10 Aug 2020
Australian start-ups push for bigger role in vaccine making
9 August 2020 - An Australian startup racing to develop a successful coronavirus vaccine has urged the federal government to ...
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 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. ...