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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The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children

23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...

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Brukinsa (zanubrutinib) receives marketing authorisation for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain by MHRA

19 January 2023 - Brukinsa is the only treatment authorised for marginal zone lymphoma in Great Britain ...

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TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine

23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...

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TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration

20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...

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China’s drug pricing policy impedes biotech profits

23 January 2023 - Beijing’s push to boost the sector has been undermined by reimbursement rules. ...

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RenalGuard Therapy receives FDA breakthrough device designation for prevention of cardiac surgery associated AKI

20 January 2023 - CardioRenal Systems announced today that the FDA granted breakthrough device designation for its RenalGuard Therapy device ...

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Mum's push for cystic fibrosis treatment to be subsidised for children under 12

23 January 2023 - Mila was diagnosed with cystic fibrosis aged just one, after experiencing lung failure in hospital, and ...

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DualityBio announces DB-1303 granted fast track designation by the US FDA for the treatment of advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression

20 January 2023 - Duality Biologics announced that the US FDA has granted fast track designation to DB-1303 for the treatment ...

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Pharmaceuticals campaigner moving to Australia after drug she desperately needs for spinal muscular atrophy is only funded for under 18s

22 January 2023 - This week, PHARMAC announced it was looking to fund a second drug to treat the neurological ...

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Sources of innovation in gene therapies - approaches to achieving affordable prices

21 January 2023 - Gene therapies are a fast growing area of innovation and potentially hold great promise for clinical care.  ...

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RemeGen announces two indications for anti-HER2 antibody drug conjugate disitamab vedotin included in China's National Reimbursement Drug List for 2023

20 January 2023 - RemeGen is pleased to announce that as of 18 January 2023, two indications for the Company's ...

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Novartis warns US plan to curb drug prices could hit key research

21 January 2023 - US Government plans to rein in drug prices could discourage work in some of Novartis' most ...

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China's first and only approved third generation BCR-ABL inhibitor olverembatinib included into the 2022 National Reimbursement Drug List

18 January 2023 - Ascentage Pharma and Innovent Biologics today announced that the novel drug olverembatinib has been included into the ...

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Assessing and extending California’s insulin manufacturing initiative

19 January 2023 - Set against the backdrop of current debates about lowering drug costs, lowering the price of insulin—a lifesaving ...

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For only the second time, a big drug maker offers a warranty on a medicine

19 January 2023 - In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty ...

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