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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NICE backs Biogen’s Vumerity for multiple sclerosis

13 April 2022 - Patients with relapsing-remitting multiple sclerosis in England, Wales and Northern Ireland can now access treatment with ...

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Why the drug pricing debate is focused on insulin

13 April 2022 - The treatment has been around for over a century but insulin has still become the centre ...

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Committee releases report uncovering significant conflicts of interest at McKinsey related to work for FDA and opioid manufacturers

13 April 2022 - Chairwoman Maloney calls on McKinsey’s global managing partner to testify at public hearing. ...

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FDA takes important steps to increase racial and ethnic diversity in clinical trials

13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...

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Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain

13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...

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European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer

13 April 2022 - Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior ...

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BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy

13 April 2022 BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with ...

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ICER releases draft evidence report on gene therapy for beta thalassaemia

13 April 2022 - Public comment period now open until 10 May 2022; requests to make oral comment during public ...

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Daratumumab monotherapy for treating relapsed and refractory multiple myeloma

13 April 2022 - NICE has published evidence based recommendations on the use of daratumumab (Darzalex) for the treatment of ...

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Highest risk COVID-19 patients receive ‘brilliant’ new antivirals at home

9 April 2022 - Thousands of patients with COVID-19 who are most likely to be admitted to hospital are receiving ...

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TGA approves Lumakras

13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...

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US FDA grants fast track designation for Paradigm’s Phase 3 osteoarthritis program

12 April 2022 - Paradigm Biopharmaceuticals is pleased to announce that the U.S. FDA has granted fast track designation for ...

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Health Canada has approved Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis

12 April 2022 - Zeposia is the first and only S1P receptor modulating agent approved for the treatment of ulcerative ...

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Jardiance (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction

12 April 2022 - Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in ...

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EMA and the EUnetHTA 21 consortium set priorities for their collaboration

12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...

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