Even drugs winning fast-track nods frustrate before reimbursement wall

27 April 2023 - Several targeted agents for lung cancer approved through fast-track review due to their innovativeness and urgency ...

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Time taken for PHARMAC funding decisions ‘too long’, says Medicines NZ

26 April 2023 - It takes the nation's drug-buying agency, PHARMAC, an average of 7.7 years to make funding decisions ...

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Publication of stage 1 and stage 2 PBS process improvements metrics report (2021-22)

21 April 2023 - The 2021-22 Stage 1 and Stage 2 PBS process improvements metrics report is now available. ...

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Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA

20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for the new ...

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Price of a life: Australians wait two years longer for breakthrough medicines than US citizens

16 April 2023 - Australians are waiting two years longer to access new lifesaving subsidised medicines because of pharma giants. Now, ...

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Faster UK drug approvals by relying on other countries

5 April 2023 - Safety and efficacy must be prioritised ahead of speed. ...

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BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A

7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...

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Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now

24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...

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Astellas provides update on fezolinetant new drug application in US

20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority ...

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Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage

17 February 2023 - Eisai anticipates about 100,000 patients diagnosed will be eligible for the drug by year three of its ...

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Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

16 February 2023 - EMA marketing authorisation application for leniolisib changed to standard review timetable. ...

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Like Medicare, the PBS urgently needs overhauling – for all our sakes

10 February 2023 - Trent Zimmerman says it would be a mistake for Australia to narrow its health reform agenda ...

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Speeding up access to new medicines in Scotland: abbreviated process

8 February 2023 - A process brought in to streamline decision-making around access to new medicines in NHSScotland during the ...

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argenx receives notification of PDUFA date extension for SC efgartigimod

27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...

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Draft methods (version 7.0): IQWiG is extending the comment period

26 January 2023 - The new deadline is 28 February 2023. ...

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