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RSS FeedPosted by Michael Wonder on 12 Aug 2020
Theranexus and BBDF obtain orphan drug designation and rare paediatric disease designation from the FDA for BBDF-101 for Batten disease
11 August 2020 - Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases, and Beyond Batten Disease Foundation ...
Posted by Michael Wonder on 11 Aug 2020
Trump’s call for essential drugs to be made in US threatens innovation, says trade group
11 August 2020 - The trade group for the US pharmaceutical industry has warned that President Donald Trump’s latest executive ...
Posted 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 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
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. ...
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 ...