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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FDA approves first NGS based companion diagnostic to aid in selecting non-small-cell lung cancer patients with HER2 (ERBB2) activating mutations (SNVs & exon 20 insertions) for treatment with Enhertu

12 August 2022 - This approval marks the Oncomine Dx Target Test’s eighth companion diagnostic therapy selection indication ...

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NICE publishes first draft guidance from its Early Value Assessment pilot project recommending smartphone linked ECG device

12 August 2022 - It is the first recommendation to be issued by NICE’s diagnostics advisory committee via its Early Value ...

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Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld

12 August 2022 - Half a million people in the UK with conditions like blood cancer that prevents them being ...

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US move to negotiate drug prices a rare defeat for big pharma

12 August 2022 - Big pharma spent more than any other industry to lobby Congress and federal agencies this year, ...

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NICE recommendation expands patient eligibility for AbbVie’s Ozurdex

12 August 2022 - Treatment becomes an option for treating visual impairment caused by diabetic macular oedema, regardless of lens ...

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For the second time, Pfizer tries a warranty in response to concerns over high drug costs

8 August 2022 - For only the second time, Pfizer is offering a warranty for a medicine that will cover ...

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2022-2023 cost recovery implementation statement

12 August 2022 - The 2022-23 PBS and NIP cost recovery implementation statement is now available.  ...

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Enhertu approved in the U.S. as the first HER2 directed therapy for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer

12 August 2022 - Based on DESTINY-Lung02 results which showed Daiichi Sankyo and AstraZeneca’s Enhertu reported a confirmed objective response ...

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Lynparza receives Health Canada approval as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer

11 August 2022 - First and only approved medicine targeting germline BRCA mutations in high-risk early breast cancer. ...

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NICE lung cancer treatment pathways

11 August 2022 - As part of our commitment to identifying transformational care for the benefit of patients, NICE has ...

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COVID-19 vaccine safety report (11 August 2022)

11 August 2022 - To 7 August 2022, the TGA has received 665 reports which have been assessed as likely to ...

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FDA approves capmatinib for metastatic non-small-cell lung cancer

11 August 2022 - On August 10, 2022, the FDA granted regular approval to capmatinib (Tabrecta, Novartis) for adult patients ...

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SMC approve Johnson & Johnson’s systemic light chain amyloidosis therapy

10 August 2022 - Newly diagnosed patients will become the first to access systemic light chain amyloidosis treatment in the ...

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MHRA grants marketing authorisation for Novartis’ radioligand therapy Pluvicto (lutetium (Lu 177) vipivotide tetraxetan) in advanced prostate cancer in Great Britain

11 August 2022 - Locamet (gozetotide), a PSMA targeted positron emission tomography imaging tracer, has also received a licence from the ...

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aTyr Pharma receives FDA fast track designation for efzofitimod (ATYR1923) for treatment of pulmonary sarcoidosis

11 August 2022 - Company is investigating efzofitimod in global pivotal Phase 3 EFZO-FIT study in pulmonary sarcoidosis patients. ...

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