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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Novartis announces FDA approval of Beovu for the treatment of diabetic macular oedema

1 June 2022 - Approval is based on year one data from the Phase III KESTREL and KITE clinical trials investigating ...

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EMA appoints Chief Medical Officer

1 June 2022 - Steffen Thirstrup has been appointed as Chief Medical Officer of the EMA.  ...

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NICE recommends potentially life-changing treatment for people with short bowel syndrome

1 June 2022 - A potentially life-changing treatment has been recommended for people with short bowel syndrome who are aged ...

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Filgotinib maleate for patients with moderate to severe active ulcerative colitis

1 June 2022 - NICE has published evidence based recommendations on the use of filgotinib maleate (Jyseleca) for the treatment ...

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FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A

1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and ...

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Government response to independent PHARMAC review

1 June 2022 - The Government has released its response to the recommendations of the final report of the independent ...

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argenx announces the UK MHRA has granted early access to efgartigimod for generalised myasthenia gravis

31 May 2022 - Efgartigimod was granted a promising innovative medicine designation by UK’s MHRA in November 2021. ...

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Swiss drug prices still soar above European levels

31 May 2022 - Compared with nine other European countries, Switzerland remains a high-price island for medicines, according to an annual ...

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Schedule of Pharmaceutical Benefits - 1 June 2022

1 June 2022 - The June 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Y-mAbs Announces FDA acceptance of biologics license application for Omblastys (omburtamab) for the treatment of neuroblastoma for priority review

31 May 2022 - Y-mAbs Therapeutics today announced that the biologics license application for Omblasyts (omburtamab) for the treatment of paediatric ...

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Priothera receives fast track designation for mocravimod in combination with allogeneic haematopoietic stem cell transplant for post remission therapy of acute myeloid leukaemia patients

31 May 2022 - Priothera today announces that the U.S. FDA has granted fast track designation for mocravimod in combination with ...

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New Zealand Pharmaceutical Schedule - 1 June 2022

1 June 2022 - The June 2022 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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Timber Pharmaceuticals receives FDA breakthrough therapy designation for TMB-001 for the treatment of congenital ichthyosis

31 May 2022 - Company preparing to dose first patients in pivotal Phase 3 ASCEND clinical trial. ...

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TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab to treat patients with RMS

31 May 2022 - New PDUFA goal date of 28 December 2022. ...

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US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027 for the as needed treatment or prevention of symptoms in asthma patients

31 May 2022 - Results from Phase 3 trials conducted by Avillion in over 4,000 patients show that PT027, a novel ...

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