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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 16 Jun 2021
Novartis prostate cancer drug receives U.S. FDA breakthrough designation
17 June 2021 - Swiss drugmaker Novartis has received breakthrough therapy designation from the U.S. FDA for an experimental treatment ...
Posted by Michael Wonder on 16 Jun 2021
United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review
16 June 2021 - FDA action expected in October 2021. ...
Posted by Michael Wonder on 16 Jun 2021
Braeburn resubmits new drug application for Brixadi (buprenorphine) extended release subcutaneous injection for moderate to severe opioid use disorder
15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous ...
Posted by Michael Wonder on 15 Jun 2021
6 ways the FDA’s approval of Aduhelm does more harm than good
15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs ...
Posted by Michael Wonder on 15 Jun 2021
FDA approves StrataGraft for the treatment of adults with thermal burns
15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...
Posted by Michael Wonder on 15 Jun 2021
Hugel America announces U.S. FDA acceptance of biologics license application for letibotulinumtoxinA for injection to treat glabellar (frown) lines
15 June 2021 - Prescription Drug User Fee Act target action date of 31 March 2022. ...
Posted by Michael Wonder on 15 Jun 2021
Eton Pharmaceuticals announces FDA approval of Rezipres (ephedrine hydrochloride injection)
15 June 2021 - Eton Pharmaceuticals today announced that the U.S. FDA has approved Rezipres (ephedrine hydrochloride injection) for the treatment ...
Posted by Michael Wonder on 15 Jun 2021
Cerevel Therapeutics announces fast track designation granted by the US FDA to CVL-871 for the treatment of dementia related apathy
15 June 2021 - Cerevel Therapeutics announced that the US FDA has granted fast track designation to CVL-871, a D1/D5 ...
Posted by Michael Wonder on 15 Jun 2021
Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform
10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...
Posted by Michael Wonder on 15 Jun 2021
Istari Oncology announces FDA granted fast track designation to PVSRIPO for the treatment of advanced melanoma
14 June 2021 - Istari Oncology announced today the U.S. FDA has granted fast track designation to PVSRIPO for the ...