Hemab Therapeutics receives FDA breakthrough therapy designation for sutacimig in Glanzmann thrombasthenia

5 March 2026 - Sutacimig has potential to become a first in class prophylactic treatment for Glanzmann thrombasthenia, an inherited serious ...

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Neurogene announces FDA breakthrough therapy designation for NGN-401 gene therapy for Rett syndrome

26 February 2026 - Breakthrough therapy designation granted based on interim NGN-401 Phase 1/2 data demonstrating clinically meaningful, durable and multi-domain ...

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Vanda Pharmaceuticals announces FDA approval of Bysanti (milsaperidone) for the treatment of bipolar I disorder and schizophrenia - a new chemical entity opening new horizons in psychiatric innovation

20 February 2026 - - Vanda Pharmaceuticals today announced that the US FDA has approved Bysanti (milsaperidone) tablets, a first ...

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CMS announces selection of drugs for third cycle of Medicare drug price negotiation program, including first ever Part B drugs

27 January 2026 - The Centers for Medicare & Medicaid Services announced the selection of 15 high cost prescription drugs covered ...

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Business Council urges unlocking ‘Aladdin's cave’ of Medicare data to save lives, health system

17 November 2025 - Unlocking an “Aladdin’s cave” of Medicare data is the key to saving Australia’s celebrated health system ...

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DoH publishes revised agenda for May 2025 PBAC meeting in June!

4 June 2025 - The DoH has published a revised agenda for last month's PBAC meeting. ...

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Trump Administration rejects expanding Medicare, Medicaid coverage of obesity drugs

4 April 2025 - Biden Administration had proposed late last year coverage of the popular medicines for obesity. ...

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Cost sharing for preferred branded drugs in Medicare Part D

14 February 2025 - Most individuals in the US are concerned about prescription drug affordability. ...

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Cell and gene therapies - improving access and outcomes for Medicare and Medicaid beneficiaries

1 February 2025 - State Medicaid agencies can now apply to participate in a new model that supports voluntary, outcomes-based agreements ...

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Ozempic among the next drugs up for Medicare price negotiations

17 January 2025 - List of drugs account for $41 billion in annual Medicare spending, Biden administration says. ...

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HHS announces cost savings for 64 prescription drugs thanks to the Medicare Prescription Drug Inflation Rebate Program established by the Biden-Harris Administration’s lower cost prescription drug law

20 December 2024 - Under the Inflation Reduction Act, some people with Medicare will pay less for some Part B ...

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Biden-Harris Administration takes next steps to increase access to sickle cell disease treatments

4 December 2024 - Today, the Biden-Harris Administration announced that two drug manufacturers with FDA approved gene therapies for sickle ...

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Biden-Harris Administration announces Medicare Advantage and Medicare Part D prescription drug proposals that aim to improve care and access for enrollees

26 November 2024 - Today, the CMS is proposing actions in the Medicare Advantage and Medicare Part D prescription drug programs ...

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Representativeness of studies required under Medicare’s coverage with evidence development program

13 November 2024 - Medicare beneficiaries are often inadequately represented in clinical studies supporting US Food and Drug Administration medical product ...

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The sickest patients are fleeing private Medicare plans costing taxpayers billions

11 November 2024 - Medicare Advantage patients in the last year of life were far more likely to switch to traditional ...

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