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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Jemperli approved by the TGA

2 March 2022 - Dostarlimab is an anti-programmed cell death protein 1 immunoglobulin G4 humanised monoclonal antibody, derived from a stable ...

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ATAGI recommends Novavax for use as a COVID-19 booster

2 March 2022 - The Australian Technical Advisory Group on Immunisation has recommended the use of the Novavax vaccine as a ...

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Teva Canada welcomes public drug plan reimbursement by Alberta, Saskatchewan, Québec, Veteran Affairs Canada and the non-insured health benefits program for patients prescribed Ajovy (fremanezumab) for the preventive treatment of migraine in adults

2 March 2022 - Public formulary and program coverage makes AJOVY® accessible to more migraine patients across Canada. ...

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BeiGene hits major milestone with first PBS approved cancer treatment

1 March 2022 - BeiGene is welcoming the listing of Brukinsa (zanubrutinib), a targeted treatment for mantle cell lymphoma, an aggressive ...

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Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women

2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...

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Advanced Innovative Partners announces designation for rare paediatric disease drug

1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...

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U.S. law makers seek answers on 'troubling' drug price increases

1 March 2022 - Senators Elizabeth Warren and Amy Klobuchar and 11 other U.S. law makers pressed the president of ...

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Progression-free survival: it is time for a new name

1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...

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Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline

1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...

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Cormedix announces resubmission of new drug application for Defencath

28 February 2022 - CorMedix today announced that it has resubmitted the new drug application for DefenCath to address the ...

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DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy

23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...

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ALS Canada marks Rare Disease Day 2022 by calling on Ontario to champion expedited access to ALS therapies

28 February 2022 - The ALS Society of Canada Cana today marks Rare Disease Day 2022 by calling on the ...

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Pharmaceutical Benefits Scheme: Pharmacy Guild of Australia say medication becoming unaffordable

1 March 2022 - A western Sydney pharmacist said Australians take pride in a universal healthcare system but “the universe doesn’t ...

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Shionogi files for approval of S-217622, a therapeutic drug for COVID-19, in Japan

25 February 2022 - Shionogi today announced that Shionogi has completed the analysis of primary endpoints a), b) in the Phase ...

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Lenvima (lenvatinib) plus Keytruda (pembrolizumab) approved in Japan for radically unresectable or metastatic renal cell carcinoma

25 February 2022 - Results from CLEAR/KEYNOTE-581 showed Lenvima plus Keytruda significantly reduced the risk of disease progression or death by ...

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