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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Large employer group launches pharmacy benefit management business

26 October 2021 - A non-profit coalition of nearly 40 companies, including U.S. retailers Walmart and Costco, said on Monday it ...

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Cystic fibrosis medicine added to PHARMAC's options for investment list

27 October 2021 - PHARMAC has announced that Vertex’s triple combination modulator therapy, known in some countries as Trikafta, has ...

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Lilly pipeline success strengthens future growth potential

27 October 2021 -  Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...

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MHRA licenses Ryeqo for symptoms of uterine fibroids

26 October 2021 - The Medicines and Healthcare products Regulatory Agency has licensed Gedeon Richter UK’s Ryeqo (relugolix combination therapy) ...

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Geron enters new innovative licensing and access pathway in the United Kingdom for imetelstat

25 October 2021 - Innovation Passport Designation Awarded to Imetelstat for the Treatment of Lower Risk Myelodysplastic Syndromes. ...

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Theratechnologies announces reimbursement agreement in Italy for Trogarzo for eligible patients with multi-drug resistant HIV-1

26 October 2021 - Theratechnologies  is pleased to announce that it has reached an agreement with the Italian Medicines Agency, AIFA, ...

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Eyenovia announces reclassification of MydCombi as drug device combination product by FDA

25 October 2021 - Company received complete response letter with additional requests and is preparing necessary documents for expedited resubmission, ...

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Bausch + Lomb and Clearside Biomedical announce FDA approval of Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular oedema Associated with Uveitis

25 October 2021 - Xipere is the first and only medicine to be approved in the United States for delivery ...

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NICE draft guidance does not recommend tucatinib for advanced breast cancer

26 October 2021 - NICE has today published draft guidance for public consultation which does not recommend tucatinib (Tukysa; Seagen), in ...

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Generating high quality evidence from registry based studies

26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on ...

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The challenges of inadequate financial support for Australians with cancer

21 October 2021 - The publicly funded Medicare system in Australia has been recognised as a leading universal health care model. ...

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Spikevax: EMA recommendation on booster

25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...

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Merck and Ridgeback announce initiation of a rolling review by the European Medicines Agency for molnupiravir, an investigational oral anti-viral medicine, for the treatment of COVID-19 in adults

25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...

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The risks of government negotiation of drug prices

25 October 2021 - Under the guise of Medicare ‘negotiations,’ the US House of Representatives is considering a measure that would ...

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Drug pricing reform opponents win most pharma lobbying money

26 October 2021 - Democratic Party law makers holding up proposed drug pricing reforms are among the largest beneficiaries of the ...

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