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 ...

Read more →

United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review

16 June 2021 - FDA action expected in October 2021. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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. ...

Read more →

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 ...

Read more →