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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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‘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 ...

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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 ...

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