Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown

22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...

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NICE terminates yet another appraisal of daratumumab

22 September 2021 - This is the third terminated appraisal of daratumumab. ...

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TGA approves Leqvio

22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...

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Thousands of Australians waiting for 'gamechanger' cystic fibrosis drug

22 September 2021 - Adelaide woman Genevieve Handley has lived with cystic fibrosis all of her life. ...

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Australia eyes Pfizer’s Covid-19 vaccines for kids aged 5 to 11

21 September 2021 - Australian health officials have confirmed if approved the vaccine would be made widely available to children ...

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bluebird bio submits biologics license application to FDA for betibeglogene autotemcel (beti-cel) gene therapy for patients with β-thalassaemia who require regular red blood cell transfusions

21 September 2021 - Biologics license application submission based on data from Phase 1/2 and Phase 3 Northstar studies, which ...

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Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis

21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...

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Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis

21 September 2021 - Opzelura is the first and only topical Janus kinase inhibitor approved in the United States. ...

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U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)

21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...

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Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19

21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...

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EU-HTA regulation: methodical preparations for implementation start with IQWiG and G-BA

21 September 2021 - The institute and the G-BA are part of a consortium that is developing the methodological basis ...

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FDA authorises software that can help identify prostate cancer

21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...

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FDA approves Lexette for adolescent plaque psoriasis

21 September 2021 - Mayne Pharma is pleased to announce that the U.S. FDA has approved Lexette (halobetasol propionate) foam, ...

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NHS patients gain access to COVID-19 treatment Ronapreve

21 September 2021 - The UK has secured supply of Ronapreve, a new COVID-19 therapeutic developed by Regeneron and Roche ...

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Rhythm Pharmaceuticals completes submission of supplemental new drug application to U.S. Food and Drug Administration for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström syndromes

20 September 2021 - Rhythm Pharmaceuticals today announced that it has completed its supplemental new drug application to the U.S. FDA ...

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