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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TG Therapeutics submits biologics license application to the U.S. FDA for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis

30 September 2021 - TG Therapeutics today announced the submission of a biologics license application to the U.S. FDA requesting approval ...

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Xbrane Biopharma announces that partner Stada's marketing authorisation application for ranibizumab is submitted and validated by European Medicines Agency

30 September 2021 - Xbrane Biopharma today announces that a marketing authorisation Application for biosimilar ranibizumab submitted by its co-development ...

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NICE terminates another two appraisals

29 September 2021 - Four terminations for the month. ...

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U.S. House panel approves fourth bill aimed at drug prices

30 September 2021 - The U.S. House Judiciary Committee voted Thursday to approve a fourth bill aimed at tackling high ...

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DiaMedica Therapeutics announces fast track designation granted to DM199 for the treatment of acute ischaemic stroke

30 September 2021 - DiaMedica Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s lead ...

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Schedule of Pharmaceutical Benefits - 1 October 2021

1 October 2021 - The October 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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FDA grants priority review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer

28 September 2021 - Novartis announced today that the US FDA has accepted and granted Priority Review to the company’s New ...

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FDA clears first major imaging device advancement for computed tomography in nearly a decade

30 September 2021 - The device uses the emerging CT technology of photon counting detectors which can measure each individual X-ray ...

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TLV gets a leading role in European HTA project

29 September 2021 - TLV is one of 13 European authorities that are now part of a project called EUnetHTA21.  ...

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People with advanced or metastatic urothelial cancer to get life-extending treatment

30 September 2021 - Around 130 people per year with untreated locally advanced or metastatic urothelial cancer will be eligible for ...

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New Zealand Pharmaceutical Schedule - 1 October 2021

1 October 2021 - The October 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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COVID-19 vaccine weekly safety report (30 September 2021)

30 September 2021 - To 26 September 2021, approximately 26.8 million vaccine doses have been given in Australia – 16.1 million ...

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Medicines industry continues to protect Australians from medicine shortages

30 September 2021 - ACCC extends approval for ongoing collaboration ...

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Acacia Pharma announces submission and validation of marketing authorisation application for Barhemsys (amisulpride injection) in major European markets

29 September 2021 - Acacia Pharma announces that its marketing authorisation application for Barhemsys (amisulpride injection) has been submitted, validated and ...

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Kesimpta: game changing multiple sclerosis drug now on PBS

30 September 2021 - A new drug that promises to change the lives of thousands of Australians living with multiple sclerosis ...

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