Health Canada has authorised CSL's Andembry (garadacimab) as once monthly treatment for hereditary angioedema

8 August 2025 - CSL today announced that Health Canada has granted a marketing authorisation for Andembry (garadacimab) for routine ...

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Labor vows to ‘fight’ as Trump threatens pharma tariffs

8 August 2025 - The Albanese government is vowing to “fight for the PBS” as Donald Trump tries to strong-arm ...

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Arvinas announces FDA acceptance of the new drug application for vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer

8 August 2025 - Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in ...

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FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

8 August 2025 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...

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Alexion, AstraZeneca Rare Disease reaches an agreement with the pan-Canadian Pharmaceutical Alliance for Ultomiris for the treatment of adults with neuromyelitis optica spectrum disorder and adults with generalised myasthenia gravis

7 August 2025 - The agreement is a critical step in ensuring adult patients living with NMOSD and gMG have ...

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Access to multiple sclerosis treatments inadequate in British Columbia

7 August 2025 - Teresa Alfeld, a filmmaker who was recently diagnosed with multiple sclerosis, is calling for the provincial ...

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PBS wait times a more urgent issue than Donald Trump's potential pharmaceutical tariffs, peak medicines body warns

7 August 2025 - Excessive wait times for medicines to be listed on the PBS are a much greater threat ...

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FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome

6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...

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The US FDA granted fast track designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma

6 August 2025 - Supporting data from a pooled analysis of Phase I/II studies of birelentinib showed an objective response ...

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NICE approves first immunotherapy combination for endometrial cancer

6 August 2025 - Around 2,100 people with advanced womb cancer are set to benefit from a groundbreaking new treatment option, ...

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FDA grants accelerated approval to dordaviprone for diffuse midline glioma

6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...

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Patients to receive medicines 3 to 6 months faster under 10 year health plan

 6 August 2025 - NICE and the MHRA have described how the 10 year health plan will lead to faster medicines ...

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How Australia is getting tangled in Trump’s fight with big pharma

6 August 2025 - The US president is angry Americans pay more for their medicines. Will he want the PBS – ...

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Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD

5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...

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Health technology assessment, again: a transparent, evidence-based approach for CMS drug price negotiations

4 August 2025 - The CMS can now negotiate the prices of a set of drugs that represent significant Medicare expenditures. ...

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