FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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MSAC consultation process - changes to take effect from 1 July 2021

16 June 2021 - MSAC is implementing changes to its consultation process from 1 July 2021.  ...

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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 ...

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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 ...

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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 ...

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MSAC Technical Guidelines - release of guidelines for preparing assessments for the Medical Services Advisory Committee (Version 1.0, May 2021)

16 June 2021 - The Department of Health is pleased to announce the publication of the Guidelines for Preparing Assessments ...

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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.  ...

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

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

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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 ...

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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. ...

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