New frontier will lead to better health outcomes

30 November 2023 - The Government has today tabled its response to an inquiry considering how to give Australian patients timely ...

Read more →

NICE gets ready to assess new dementia treatments

20 November 2023 - NICE’s methods and processes for evaluating new treatments for use in the NHS are appropriate for the ...

Read more →

To get things done fast at FDA: ‘don’t tell anybody,’ cancer chief says

15 November 2023 - The FDA’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. ...

Read more →

Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA

2 November 2023 - PDUFA target action date of 5 April 2024. ...

Read more →

Mirum Pharmaceuticals announces new PDUFA date for Livmarli for the treatment of cholestatic pruritus in progressive familial intrahepatic cholestasis

17 October 2023 - Mirum Pharmaceuticals today announced that the US FDA has extended the review of the supplemental new drug ...

Read more →

EU delays approval of Novavax's revised COVID vaccine

16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...

Read more →

Will Medicare price negotiation delay cancer drug launches?

11 October 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs selected for Medicare price ...

Read more →

Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)

20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...

Read more →

UCB provides update on US regulatory review of bimekizumab

19 September 2023 - UCB today provided an update on the biologics license application for bimekizumab for the treatment of ...

Read more →

US. FDA updates PDUFA action date for lifileucel for the treatment of advanced melanoma

14 September 2023 - FDA extends PDUFA date to 24 February 2024 on resource constraints and agrees to work with ...

Read more →

Formycon announces file acceptance for FYB203, a biosimilar candidate to Eylea (aflibercept), by the US FDA

29 August 2023 - Formycon and its license partner Klinge Biopharma announce that the US FDA has accepted the biologics license ...

Read more →

Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date

11 September 2023 - PDUFA target goal date set for 28 April 2024. ...

Read more →

Verona Pharma announces the US FDA has accepted the new drug application filing for ensifentrine for the maintenance treatment of COPD

11 September 2023 - PDUFA target action date of 26 June  2024. ...

Read more →

Geron announces PDUFA date for imetelstat NDA in lower risk MDS

22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...

Read more →

Swiss drug review times trail FDA and EMA, increased due to COVID

21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...

Read more →