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RSS FeedPosted by Michael Wonder on 17 Jun 2021
Vaccine confusion as clots force jab switch for two million
17 June 2021 - Health authorities are scrambling to switch more than two million Australians aged under 60 to the ...
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
Health care funding decisions and real world benefits: reducing bias by matching untreated patients
14 June 2021 - Governments and health insurers often make funding decisions based on health gains from randomised controlled trials. ...
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
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 U.S. FDA to CVL-871 for the treatment of dementia related apathy
15 June 2021 - Cerevel Therapeutics announced that the U.S. FDA has granted fast track designation to CVL-871, a D1/D5 ...
Posted by Michael Wonder on 15 Jun 2021
GBT’s voxelotor is first sickle cell disease treatment to receive promising innovative medicine designation in the UK
14 June 2021 - Global Blood Therapeutics announced today that the MHRA in the United Kingdom has granted a Promising Innovative ...
Posted by Michael Wonder on 15 Jun 2021
Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada
14 June 2021 - Submission supported by data from the CENTAUR trial. ...
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
Moderna seeks vaccine approval for adolescents
11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...