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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FDA offers new guidance on therapeutic equivalence evaluations

20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...

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Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis

20 July 2022 - Approval is supported by efficacy and safety data of two pivotal studies in which Rinvoq demonstrated improvements ...

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Ultra-expensive SMA drug Zolgensma to get insurance benefits from August

21 July 2022 - Novartis' Zolgensma (onasemnogene abeparvovec), the world's most expensive drug yet to treat spinal muscular atrophy, will ...

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‘Increasing problem’: Australia facing shortages of more than 320 medicines

21 July 2022 - More than 320 items are becoming hard to find as Australia faces increasing shortages in a crucial ...

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Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation

21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...

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ATAGI update following weekly COVID-19 meeting (20 July 2022)

21 July 2022 - The ATAGI met on 20 July 2022 to consider the latest developments relating to COVID-19 immunisation. ...

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TGA approves Padcev

21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...

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Simulating colorectal cancer trials using real world data

20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...

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For Medicaid insured patients with cancer, health insurance does not always mean health access

15 July 2022 - Although there has been a significant increase in the number of U.S. residents insured through Medicaid since ...

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The big squeeze?

20 July 2022 - With NHS England highlighting savings of £1.2 billion on medicines in three years coming from both ...

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FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides' Pepaxto

20 July 2022 - Oncopeptides today announces that the US FDA, has announced a forthcoming public advisory meeting of the ...

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FDA approves Qsymia for the treatment of obesity in adolescents ages 12-17

20 July 2022 - Vivus today announced that the U.S. FDA approved Qsymia (phentermine and topiramate extended-release capsules) for use in ...

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Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes

20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for ...

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Easier access to locally applied HRT to treat post-menopausal vaginal symptoms in landmark MHRA reclassification

20 July 2022 - From September women in the UK will be able to access Gina 10 microgram vaginal tablets without ...

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Statement by President Joe Biden on FDA and CDC authorising Novavax’s COVID-⁠19 vaccine for adults

19 July 2022 - Today is another step forward in our nation’s fight against the virus. Following an independent scientific review ...

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