United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19

18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...

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The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis

18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...

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3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying

18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...

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Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug

18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...

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Manchin wants Biden to oust FDA Chief over controversial Alzheimer’s drug approval

17 June 2021 - After some of the FDA’s outside advisors quit in outrage after the agency approved a controversial new ...

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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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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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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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