Minister announces parallel assessment means new medicines assessed sooner

28 February 2024 - PHARMAC is changing its process so it can assess a funding application at the same time Medsafe ...

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Terminally ill patients despair amid price war over CAR-T cancer therapy

22 February 2024 - Australia risks “being pushed to the back of the queue” of countries to gain access to ...

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UK's MHRA revokes authorisation for Novartis' sickle cell drug

21 February 2024 - Britain's health regulator said on Wednesday it had revoked a conditional marketing authorisation for Novartis' sickle ...

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COVID-19 vaccine available in March

22 February 2024 - Joint media release with Health New Zealand. ...

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The Biden Administration versus Medicare Advantage

21 February 2024 - When does the failure to answer a phone call in 8 seconds cost the company receiving the ...

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United Therapeutics starts litigation with FDA over rival Liquidia's drug application

21 February 2024 - United Therapeutics said on Wednesday it had filed a case with the US FDA, alleging that ...

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Tecvayli (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma

20 February 2024 - Biweekly dosing with Tecvayli, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility. ...

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Talazoparib tosylate for the treatment of patients with advanced BRCA mutation positive HER2 negative breast cancer (final guidance)

21 February 2024 - NICE has published final evidence-based recommendations on the use of talazoparib tosylate (Talzenna) for the treatment ...

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Linvoseltamab BLA for treatment of relapsed/refractory multiple myeloma accepted for FDA priority review

21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...

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FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma

20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...

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Omnix Medical granted fast track designation by US FDA for its next generation anti-infective OMN6

20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...

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Medera’s Sardocor announces fast track designation and dosing of 3 patients in first in human HFpEF gene therapy trial

14 February 2024 - In the Phase 1/2A clinical trial for SRD-001, an adeno-associated virus mediated first in human gene therapy ...

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Immuneering receives FDA fast track designation for IMM-1-104 in pancreatic cancer

20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...

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How Sempre Health, Mark Cuban and more are leading the charge to disrupt drug pricing

15 February 2024 - As last miles go, medication adherence – when patients take the medication that’s been prescribed to them ...

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Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis

20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...

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PepGen receives US FDA fast track designation for PGN-EDODM1 for the treatment of myotonic dystrophy type 1

20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...

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