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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On new recommendation for treatment of COVID-19 patients: WHO calls for equitable access to casirivimab and imdevimab for COVID-19

24 September 2021 - The World Health Organization welcomes the addition of another therapeutic to the world’s arsenal against COVID-19, ...

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Australia secures supply of drug that treats arthritis and Covid

25 September 2021 - Health Minister Greg Hunt has secured an extra supply of a rheumatoid arthritis drug to treat critically ...

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FDA tweaks biosimilar application review program

25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications.  ...

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Manitoba family calling for province to cover life-changing drug

26 September 2021 - A new drug called Trikafta could be a life-changing treatment option for people living with cystic ...

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Pharmacy Guild plan to halve PBS general patient charge for prescription medicine prices

26 September 2021 - The Pharmacy Guild has declared war on discount chains like Chemist Warehouse. ...

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MSAC publishes agenda for upcoming PASC meeting

24 September 2021 - The MSAC Secretariat has published a list of the applications scheduled to be considered at the next ...

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CARISMA Therapeutics announces U.S. FDA grants fast track designation to CT-0508 for the treatment of patients with solid tumours

22 September 2021 -  CARISMA Therapeutics announced today that that the U.S. FDA has granted fast track designation to CT-0508, ...

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FDA approves Repatha (evolocumab) in paediatric patients age 10 and older with heterozygous familial hypercholesterolaemia

24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol. ...

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Doctors too keen to operate, say experts

25 September 2021 - Doctors are routinely over-diagnosing and over-treating conditions that do not require medical intervention, sometimes carrying out ...

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Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada

22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...

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Ontario providing access to life changing treatment for cystic fibrosis patients

24 September 2021 - Ontario is now providing coverage for Trikafta, the latest and most effective treatment option for cystic fibrosis ...

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Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency

24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...

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ATAGI update following weekly COVID-19 meeting (22 September 2021)

24 September 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 22 September ...

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EU drugs regulator to decide on Pfizer vaccine booster in early October

23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...

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Pear Therapeutics announces additional coverage decisions and formulary adoption of its prescription digital therapeutics

23 September 2021 - More than 30 organizations now provide access to Pear’s prescription digital therapeutics by either listing on formulary, ...

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