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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ATAGI update following weekly COVID-19 meeting (9 March 2022)

11 March 2022 - ATAGI have not made any new updates since 2 March 2022. ...

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Diabetes NZ to kick-start campaign for PHARMAC funding for glucose monitors

11 March 2022 - Diabetes NZ wants PHARMAC to fund next-generation blood sugar monitors for people with the debilitating disease. ...

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Allogene Therapeutics receives FDA fast track designation for its first solid tumour candidate, ALLO-316 in the treatment of renal cell carcinoma

10 March 2022 - ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which has broad potential application across a ...

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Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma

8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...

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Solriamfetol for treating excessive daytime sleepiness caused by obstructive sleep apnoea

9 March 2022 - NICE has published evidence based recommendations on the use of solriamfetol hydrochloride (Sunosi) for the treatment ...

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Ronapreve: first COVID-19 therapeutic drug to get Medsafe's approval not effective against Omicron

10 March 2022 - The first new COVID-19 therapeutic drug to get Medsafe's approval demonstrates "significantly diminished potency" against Omicron. ...

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Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)

10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...

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Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea

 9 March 2022 - NICE has published evidence based recommendations on the use of pitolisant hydrochloride for the treatment of ...

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Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma

10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...

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AARP launches new ad showing the impact of Congress’ failure to act on prescription drug prices

10 March 2022 - AARP launched new television and digital advertising featuring Larry Zarzecki, a retired law enforcement officer with Parkinson’s ...

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SMC accepts Lumykras (sotorasib) for locally advanced or metastatic non-small cell lung cancer for use on an interim basis by NHS Scotland

7 March 2022 - Sotorasib Is indicated as monotherapy for the treatment of adult patients with KRAS G12C mutated locally advanced ...

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How will reimbursement for Tecentriq in liver cancer affect biosimilars?

10 March 2022 - Roche is negotiating with the government over the reimbursement price of Tecentriq (atezolizumab), which passed the ...

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Revance resubmits biologics license application for daxibotulinumtoxinA for injection for glabellar lines to the FDA

8 March 2022 - Revance Therapeutics today announced it has resubmitted its biologics license application to the U.S. FDA for DaxibotulinumtoxinA ...

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Thirty six medicines added to PHARMAC’s waiting list as New Zealand’s medicines crisis worsens

10 March 2022 - PHARMAC has just released its Options for Investment list, which includes 36 new medicines since it ...

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Legislation would set expiration for FDA’s accelerated approvals

9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...

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