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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Faster UK drug approvals by relying on other countries

5 April 2023 - Safety and efficacy must be prioritised ahead of speed. ...

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Are German drug pricing regulations chasing some drug makers away, causing them to withdraw products from the market?

5 April 2023 - Germany’s pharmaceutical market is the most important one on the European continent.  ...

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Global blockbusters’ failure to win insurance coverage raises questions about fairness

5 April 2023 - Here is a case in which patients' treatment options and companies' business rights have been put ...

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FDA accepts Pfizer’s supplemental new drug applications for Braftovi + Mektovi

4 April 2023 - Supplemental new drug applications are supported by results from the PHAROS trial, evaluating the combination in ...

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Shionogi receives US FDA fast track designation for ensitrelvir fumaric acid, an investigational oral anti-viral for COVID-19

4 April 2023 - Shionogi today announced that the US FDA has granted fast track designation for their investigational COVID-19 ...

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FDA authorises Gohibic (vilobelimab) injection for the treatment of COVID-19

4 April 2023 - The FDA has issued an emergency use authorisation for the use of Gohibic (vilobelimab) injection for ...

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TLV reconsiders the subsidy of Lumykras (sotorasib)

4 April 2023 - TLV has started a review of Lumykras (sotorasib). Lumykras (sotorasib) has already been included in the high-cost ...

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Long-waited drugs were approved, but patients must wait for insurance benefits

 4 April 2023 - Braftovi (encorafenib) is a targeted agent used for VRAF V600E mutant metastatic colorectal cancer patients with ...

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Daridorexant for the treatment of patients with insomnia disorder

3 April 2023 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...

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New features further strengthen Priority Medicines scheme (PRIME)

4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...

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Medicare non-compliance and fraud costing Australians

4 April 2023 - The Albanese Government has today released the findings of a review into the compliance system that underpins ...

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PHARMAC seeking feedback on the COVID-19 anti-viral molnupiravir

4 April 2023 - PHARMAC are consulting on the role of molnupiravir in New Zealand’s portfolio of COVID-19 treatments.  ...

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Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas

3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...

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HUTCHMED completes rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory metastatic colorectal cancer

31 March 2023 - NDA supported by data from global Phase 3 FRESCO-2 study in the US, Europe, Japan and Australia ...

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Chiesi Global Rare Diseases announces approval of Ferriprox MR deferiprone extended release tablets in Canada

31 March 2023 - New formulation allows twice-daily dosing in patients with transfusional iron overload due to thalassaemia syndromes when ...

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