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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TGA approves new treatment for aggressive form of prostate cancer

5 May 2021 - The TGA has registered a new medication to treat a particularly aggressive and advanced type of ...

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ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV

4 May 2021 - If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP. ...

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Australia's TGA grants approval to first objective concussion diagnostic

4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...

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Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent

4 May 2021 - Breakthrough designation helps advance treatment options, targeting a significant unmet need in the treatment of critical limb-threatening ischaemia. ...

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Uncertain effect and high prices of precision medicine are challenging

3 May 2021 - In a report to the government, the Swedish Dental and Pharmaceutical Benefits Agency, TLV, describes the most ...

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SIGA announces new drug application filing with FDA for intravenous formulation of TPOXX

4 May 2021 - Important for patients who cannot swallow oral capsules. ...

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NICE announces more people eligible for nusinersen sodium following review of Managed Access Agreement

4 May 2021 - NICE has today announced that more people with the rare genetic disorder spinal muscular atrophy are to ...

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EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated

4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...

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Clearside Biomedical announces resubmission of new drug application for Xipere for treatment of macular oedema associated with uveitis

3 May 2021 - Clearside Biomedical announced today the resubmission of its new drug application to the U.S. FDA for ...

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Astellas' Xtandi (enzalutamide) approved by European Commission for men with metastatic hormone sensitive prostate cancer

4 May 2021 - Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types ...

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Diabetes drugs: list price increases were not always reflected in net price; impact of brand competition unclear

3 May 2021 - List prices for brand-name drugs have risen steeply, often despite the introduction of competition from other brand-name ...

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Andrew Little not pleased with Children's Commissioner comments on potential PHARMAC move

4 May 2021 - Heath Minister Andrew Little says he expects better of the Children's Commissioner after he described a potential ...

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Doubt over local mRNA plans as major companies pull out of Australia

3 May 2021 - Vaccine development experts say it will take at least $250 million plus the support of a ...

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Amphastar Pharmaceuticals receives FDA approval for morphine sulphate injection

3 May 2021 - Amphastar Pharmaceuticals announced that the U.S. FDA approved the Company’s abbreviated new drug application for morphine sulphate ...

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TLV reconsiders subsidy for eleven TNF alfa inhibitors included in the high-cost protection

30 April 2021 - Today, eleven subcutaneous TNF-alpha inhibitors are included in the high-cost protection. ...

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