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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Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

20 August 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) for the treatment of active polyarticular ...

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TGA grants provisional determination to Celltrion Healthcare's anti-viral COVID-19 treatment regdanvimab

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare in relation to regdanvimab. ...

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TGA grants provisional determination to Roche combination COVID-19 treatment casirivimab and imdevimab (Ronapreve)

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Roche in relation to the combination ...

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ATAGI update following weekly COVID-19 meeting (18 August 2021)

23 August 2021 - ATAGI met on Wednesday 18 August 2021 to review the latest developments relating to COVID-19 and COVID-19 ...

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Dulaglutide receives Medsafe approval

23 August 2021 - Dulaglutide will be funded from 1 September 2021. ...

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White House to House Democrats: drug price plan is a winning issue

22 August 2021 - The Biden administration is touting the popularity of its prescription drug proposal as it works to convince ...

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Accelerated approval - an unexpected pathway to value-based pricing?

18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...

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TGA approves new COVID-19 treatment for use in Australia

20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...

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Competition, consolidation and evolution in the pharmacy market

12 August 2021 - Implications for efforts to contain drug prices and spending. ...

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Cystic fibrosis patients, advocates urge Ontario government to provide ‘miracle drug’ funding

20 August 2021 - An Ontario teen living with Cystic Fibrosis and her mother are hoping to shine a light ...

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FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

20 August 2021 - On 19 August 2021, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of ...

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UK authorises Regeneron antibody cocktail to prevent and treat acute COVID-19 infection

20 August 2021 - UK chief medical officers to confirm how antibody cocktail will be rolled-out on the National Health ...

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NICE draft guidance extends recommendation for sapropterin to pregnant women and people aged up to 22 years with rare inherited metabolic condition phenylketonuria

20 August 2021 - NICE has today issued final draft guidance which now recommends sapropterin (Kuvan; BioMarin) as an option for ...

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Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma

19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...

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Acting FDA Chief Janet Woodcock ruled out as Biden nominee

19 August 2021 - Woodcock faced backlash over controversial Alzheimer’s drug. ...

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