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RSS FeedPosted by Michael Wonder on 18 Jun 2021
Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
18 June 2021 - Orphazyme today announced it has received a complete response letter from the U.S. FDA following its ...
Posted by Michael Wonder on 17 Jun 2021
Furore rages over FDA approval of controversial Alzheimer’s drug
17 June 2021 - Critics attack the agency’s action as reckless, but defenders say patients will benefit. ...
Posted by Michael Wonder on 17 Jun 2021
Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases
17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...
Posted by Michael Wonder on 17 Jun 2021
The FDA is in desperate need of some soul-searching
17 June 2021 - Ordinarily, the approval of a new drug for a dreaded disease affecting millions of Americans would be ...
Posted by Michael Wonder on 17 Jun 2021
Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab
17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...
Posted by Michael Wonder on 17 Jun 2021
Agenus announces U.S. FDA acceptance and priority review of balstilimab biologics license application for the treatment of recurrent or metastatic cervical cancer
17 June 2021 - Agenus today announced that the U.S. FDA has accepted Agenus’ biologics license application for balstilimab, an ...
Posted by Michael Wonder on 17 Jun 2021
FDA approves a nasal anti-histamine for non-prescription use
17 June 2021 - The U.S. FDA today approved a nasal antihistamine for nonprescription use through a process called a partial ...
Posted by Michael Wonder on 17 Jun 2021
Applied Therapeutics granted fast track designation by FDA for AT-007 for galactosaemia
17 June 2021 - Applied Therapeutics today announced that the U.S. FDA has granted fast track designation to AT-007 for the ...
Posted by Michael Wonder on 17 Jun 2021
A life-saving new drug for COVID-19 is found
16 June 2021 - But only rich countries will benefit, and even they will struggle to get hold of it. ...
Posted by Michael Wonder on 17 Jun 2021
Eagle Pharmaceuticals submits response to complete response letter from FDA for vasopressin
17 June 2021 - Eagle Pharmaceuticals today announced that it has responded to the complete response letter for its abbreviated ...
Posted by Michael Wonder on 17 Jun 2021
Statement in response to latest ATAGI advice regarding COVID-19 vaccines
17 June 2021 - A statement from the Professor Paul Kelly, Australian Government Chief Medical Officer in response to the latest ...
Posted by Michael Wonder on 17 Jun 2021
COVID-19 vaccine weekly safety report (17 June 2021)
17 June 2021 - Twelve additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 16 Jun 2021
VoluMetrix's NIVA|HF for heart failure patients designated as breakthrough device by U.S. FDA
15 June 2021 - NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart ...
Posted by Michael Wonder on 16 Jun 2021
‘A litany of flaws’: advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval
16 June 2021 - Reacting to the controversial approval of the Biogen Alzheimer’s drug, a leading advocacy group is urging ...
Posted by Michael Wonder on 16 Jun 2021
FDA approves avapritinib for advanced systemic mastocytosis
16 June 2021 - On June 16, 2021, the FDA approved avapritinib (Ayvakit, Blueprint Medicines) for adult patients with advanced ...