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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Mark Cuban Cost Plus Drug Company and OncoPower team up to bring medication adherence and cost savings to cancer patients

30 January 2023 - Collaboration focuses on pricing transparency, affordable access, and engaging patients at home to ensure treatment adherence. ...

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Simcere’s COVID-19 pill goes on sale in China at less than half the price of Pfizer’s Paxlovid

31 January 2023 - The retail price of Simcere Pharmaceutical’s orally taken COVID-19 treatment, which was only approved to go ...

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Nintedanib esylate for the treatment of adults with idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted

1 February 2023 - Nintedanib esylate is recommended as an option for the treatment of adults with idiopathic pulmonary fibrosis ...

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ABPI response to new MHRA fees announced for 1 April 2023

1 February 2023 - These fee increases are an important step to ensuring the MHRA has the resources it needs ...

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Somatrogon for treating growth disturbance in people 3 years and over

1 February 2023 - Somatrogon is recommended as an option for the treatment of children 3 years of age and over ...

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Mesoblast resubmits biologic license application to FDA for remestemcel-L in children with steroid-refractory acute graft versus host disease

31 January 2023 - New 4 year data from the Phase 3 trial shows durable long term survival outcomes. ...

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Trastuzumab deruxtecan for treating HER2 positive unresectable or metastatic breast cancer after one or more anti-HER2 treatments

1 February 2023 - Trastuzumab deruxtecan is recommended with managed access as an option for the treatment of adults with HER2 ...

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Artiva Biotherapeutics receives FDA fast track designation for AB-101

31 January 2023 - Granted fast track designation by US FDA for the treatment of relapsed/refractory non-Hodgkin lymphoma of B cell ...

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Upadacitinib monohydrate for the treatment of patients with active non-radiographic axial spondyloarthritis

1 February 2023 - Upadacitinib monohydrate is recommended as an option for the treatment of adults with active non-radiographic axial ...

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Changes applying to evaluation of new substances for listed medicines

1 February 2023 - The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD ...

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New Parkinson's disease treatment added to PBS

1 February 2023 - From 1 February, Australians with Parkinson’s disease will have access to a new medicine on the PBS. ...

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Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...

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US health care from a global perspective, 2022: accelerating spending, worsening outcomes

31 January 2023 - In the previous edition of US Health Care from a Global Perspective, we reported that people ...

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Jazz Pharmaceuticals receives NICE recommendation for the reimbursement of Epidyolex (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex in England

31 January 2023 - Jazz Pharmaceuticals today announced that Epidyolex (cannabidiol 100 mg/mL oral solution), developed by GW Pharmaceuticals, has been ...

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A watershed year for biosimilars — if regulators and policy makers step up

31 January 2023 - 31 January is set to mark the start of a watershed year for the biosimilars industry ...

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