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RSS FeedPosted 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
TLV receives a new assignment for precision medicine and advanced therapy drugs
15 June 2021 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, is commissioned by the government to continue the ...
Posted by Michael Wonder on 16 Jun 2021
Sanders 'delighted' DeSantis asked White House to import Canadian prescription drugs
16 June 2021 - Senator Bernie Sanders said in an interview published on Wednesday that he was "delighted" that Florida ...
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
Sweden's cost of medicines is increasing
15 June 2021 - Sweden's costs for pharmaceuticals have risen by approximately SEK 2 billion between 2019 and 2020. ...
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 16 Jun 2021
Medicare must study unproven, expensive Alzheimer’s drug
15 June 2021 - Tax payers and patients cannot afford to pay a high price for a treatment not known to ...
Posted by Michael Wonder on 16 Jun 2021
Emmaus Life Sciences announces submission of marketing authorisation application to Swissmedic; Ideogen to manage early access program
15 June 2021 - Emmaus Life Sciences anounced today it has received confirmation from the Swiss Agency for Therapeutic Products ...
Posted by Michael Wonder on 15 Jun 2021
How the patient voice is becoming vital for drug approval
14 June 2021 - Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a ...
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
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 ...