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 authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals

29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...

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Nurix Therapeutics awarded Innovation Passport for entry into Innovative Licensing and Access Pathway in the United Kingdom for NX-1607

29 March 2022 - NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumour types. ...

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European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer

29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete ...

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Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA

29 March 2022 - Priority review granted by U.S. FDA. ...

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Federal budget 2022: more funding for breast cancer drug Trodelvy

29 March 2022 - Against all the odds Sydney mum Alison Day will get to celebrate her daughter’s 12th birthday — ...

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Lipocine announces its partner received FDA approval of Tlando

29 March 2022 - Commercial launch expected in 2Q 2022. ...

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Government fails to adequately address medicine affordability for working Australians

29 March 2022 - The cost of medicines will continue to go up unchecked as the Federal Government has failed ...

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Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes

28 March 2022 - Ozempic demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes ...

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Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy

29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...

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Consequences of US FDA approval decisions in high-income countries

29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...

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Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

28 March 2022 - Daiichi Sankyo today announced that it has obtained approval in Japan to change the indication of ...

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Budget 2022-23 – no ‘big bang’ announcements in health

29 March 2022 - Medicines Australia welcomes tonight’s Budget announcements for new PBS listings and on-going COVID-19 measures. ...

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Record investment in the future of Australia's health system

29 March 2022 - The Australian Government is investing in a stronger health system as part of our plan for a ...

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Neurocrine Biosciences announces regulatory approval of Dysval (valbenazine) for the treatment of tardive dyskinesia in Japan

29 March 2022 - Neurocrine Biosciences today announced that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, has obtained regulatory approval of ...

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Ondexxya approved in Japan for reversal of acute major bleeds in patients on factor Xa inhibitors

29 March 2022 - Ondexxya is the first approved reversal agent specifically for factor Xa inhibitors, providing a major advance ...

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