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NICE draft guidance extends recommendation for sapropterin to pregnant women and people aged up to 22 years with rare inherited metabolic condition phenylketonuria

20 August 2021 - NICE has today issued final draft guidance which now recommends sapropterin (Kuvan; BioMarin) as an option for ...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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Recommendations made by the PBAC – July 2021

20 August 2021 - Recommendations made by the PBAC in July 2021 relating to the listing of medicines on the PBS ...

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TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)

20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...

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Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease

20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...

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CADTH welcomes transfer of drug safety and effectiveness network

13 August 2021 - CADTH welcomes today’s announcement by the Canadian Institutes of Health Research and Health Canada that they ...

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NICE’s health technology assessment methods and processes to be evaluated

19 August 2021 - NICE has launched a public consultation on proposed changes to the way it develops recommendations across ...

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Booster shots ‘make a mockery of vaccine equity,’ the WHO’s Africa director says

19 August 2021 - The Africa director at the World Health Organization, Dr. Matshidiso Moeti, criticized the decisions by some ...

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Contradicting WHO, US advises adults to receive COVID-19 boosters

19 August 2021 - The Biden administration is advising all American adults to receive a COVID-19 booster shot after accumulating ...

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EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options

19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA. ...

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EndoPredict for breast cancer - the company chose not to participate with data

19 August 2021 - In November 2020, Myriad Genetics chose to refrain from participating in a health economic assessment of EndoPredict.  ...

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