FDA accepts Telix NDA for new prostate cancer imaging agent

23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...

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Switzerland’s drug approval process lags behind Europe

24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...

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Doug Ford wants Canada to approve drugs faster. Is that possible?

15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...

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Clinical benefit, reimbursement outcomes, and prices of FDA approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis

11 July 2024 - Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in ...

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Updates to the HTA Policy and Methods Review

10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...

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HAS clarifies the framework of the “bet” on early access to medicines

24 June 2024 - Committed to a process of continuous development of its methods, the High Authority of Health is launching ...

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FDA breakthrough therapy designation reduced late-stage drug development time

1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...

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Comparing new medicine availability across Europe

12 June 2024 - Each year, the European Pharmaceutical Industry Association (EFPIA) publishes data comparing the availability of new medicines across ...

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Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections

31 May 2024 - Oral sulopenem NDA has been assigned a PDUFA action date of 25 October 2024. ...

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Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation

31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action ...

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Project Orbis: quicker access to promising cancer treatments

29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...

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NICE and NHS England announce plan to enable innovative tech to be adopted quicker

23 May 2024 - NHS patients in England will benefit from faster access to the most innovative and cutting-edge medical technologies ...

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Bristol Myers Squibb announces updated action date by the US FDA for subcutaneous nivolumab (nivolumab and hyaluronidase)

21 May 2024 - Updated PDUFA goal date of 29 December 2024. ...

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Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism

14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...

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Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis

13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...

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