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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Swissmedic issues unlimited authorisation for booster dose of Moderna's bivalent COVID-19 Original/Omicron BA.4-5 vaccine

8 March 2023 - Spikevax bivalent Original/Omicron BA.4-5 mRNA vaccine authorised for people aged 18 and over. ...

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AMA urges immediate action to save patients on PBS medicines

9 March 2023 - The AMA has urged all members of the Federal Parliament to support the AMA’s campaign to bring ...

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Patent system key to lower drug prices, experts say

9 March 2023 - Following the Biden administration’s progress towards lowering prescription drug prices with Medicare price negotiations, some industry ...

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New drugs are coming to market at sky-high prices

9 March 2023 - Trend follows rising pressure on companies to rein in repeat or annual price hikes for older drugs/ ...

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Mallinckrodt announces reimbursement approval in Japan for the Celllex extracorporeal photopheresis system for the treatment of chronic graft versus host disease

9 March 2023 - Cellex ECP is now available for reimbursement in Japan for patients who are steroid-resistant or intolerant ...

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CADTH recommends reimbursement for BioCryst’s Orladeyo (berotralstat) for the routine prevention of attacks in hereditary angioedema patients in Canada

8 March 2023 - BioCryst Pharmaceuticals today announced that the CADTH Canadian Drug Expert Committee has issued a positive recommendation ...

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Use warranties, not outcomes-based agreements, to make payers whole when a gene therapy fails

9 March 2023 - A decade ago, I had pegged gene and cell therapies as the next frontier. As an ...

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Updates from the Health Technology Assessment Policy and Methods Review Reference Committee (March 2023)

9 March 2023 - The Health Technology Assessment Policy and Methods Review Reference Committee met on 13 February 2023.  ...

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Jazz Pharmaceuticals secures eight additional provincial reimbursements for Vyxeos for treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes

8 March 2023 - Jazz Pharmaceuticals announced today that Vyxeos (daunorubicin and cytarabine liposome for injection) is now included on eight ...

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Biden calls for tax on the wealthy to extend Medicare funding

8 March 2023 - President Joe Biden this week called for higher taxes on wealthy Americans to extend Medicare funding as ...

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Preterm birth drug withdrawn after 12 years

7 March 2023 - The FDA seemed poised to rescind approval of Makena, after studies over time indicated the treatment did ...

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Amphastar Pharmaceuticals receives FDA approval for naloxone hydrochloride nasal spray 4 mg

8 March 2023 -  Amphastar Pharmaceuticals announced that the US FDA has granted approval of its new drug application for ...

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US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes

8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...

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NICE recommended weight loss drug to be made available in specialist NHS services

8 March 2023 - Thousands of people will soon be able to be prescribed a drug to help them lose weight ...

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FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response

7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...

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