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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Reneo Pharmaceuticals receives fast track designation from the FDA for mavodelpar (REN001) in a genotype of long-chain fatty acid oxidation disorder

31 January 2023 - Reneo Pharmaceuticals today announced that the US FDA has granted mavodelpar (REN001) fast track designation for long ...

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Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States

31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...

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Call for Enhertu to be registered on Pharmaceutical Benefits Scheme

31 January 2023 - Sarah Lee has been forced to use her super and life insurance to pay for the treatment. ...

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International price comparison of medicines (2022)

31 January 2023 - The price of prescription drugs in Sweden has fallen compared to other countries since 2014 and is ...

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Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway

27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...

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Distribution markups and taxes for prescription pharmaceuticals: do we see the complete picture of the pharmaceutical price?

30 January 2023 - An analysis presented at the ISPOR Europe 2021 conference highlighted considerable variability across countries in how much ...

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FDA may not always require post-approval trials to be enrolled before accelerated approvals

30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...

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Options for a reformed Prostheses List pre-listing assessment framework and governance structure

31 January 2023 - This report provides a framework and proposes options for governance that would align the Prostheses List processes ...

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Medicare drug price negotiation in the United States: implications and unanswered questions

8 December 2022 - The United States is a relatively free pricing market for pharmaceutical manufacturers to set list prices at ...

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Abbisko Therapeutics announces that US FDA has granted breakthrough therapy designation for its CSF-1R inhibitor pimicotinib (ABSK021)

30 January 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted breakthrough therapy designation ...

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Amazon’s bold $5 prescription drug program is the future of pharmacy

28 January 2023 - Amazon is taking yet another bold step into the world of health care, further solidifying its powerful ...

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Why drug makers have raised prices on nearly 1,000 drugs so far this year

30 January 2023 - With pharmaceutical companies hiking prices on nearly 1,000 drugs in January, some consumers might experience sticker ...

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US law makers call on Biden Administration to lower the price of enzalutamide

27 January 2023 - US Senator Elizabeth Warren, a Democrat from Massachusetts, and nearly two dozen other lawmakers are demanding to ...

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Alpha Biopharma submits new drug application for zorifertinib, a next generation EGFR-TKI to treat EGFR mutated NSCLC patients with CNS metastases

30 January 2023 - Alpha Biopharma announces that the Center for Drug Evaluation of the NMPA has accepted its new drug ...

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Junshi Biosciences announces approval for marketing of VV116 in China

30 January 2023 - Shanghai Junshi Biosciences announced today that the NMPA has conducted urgent review and approval under special examination ...

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