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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Krystal Biotech announces FDA’s 3 month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa

9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that ...

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Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira

22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...

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US FDA extends review of Pfizer’s new drug application for Paxlovid

20 December 2022 - Pfizer oral treatment remains available to eligible US patients under emergency use authorisation as a critical ...

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Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer

15 December 2022 - AstraZeneca and MSD today announced that the US FDA has informed AstraZeneca that it will extend ...

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IntelGenx receives FDA PDUFA date for Rizafilm

22 November 2022 - IntelGenx today announced that the US FDA has accepted for review its Class 2 response to the ...

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Gamida Cell provides regulatory update on omidubicel

21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months. ...

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Iovance Biotherapeutics provides update on biologics license application submission for lifileucel in advanced melanoma

18 November 2022 - BLA submission on-going with US FDA. ...

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Apellis announces FDA acceptance of NDA amendment and new PDUFA date of 26 February 2023 for pegcetacoplan for geographic atrophy

18 November 2022 - Apellis Pharmaceuticals today announced that the US FDA has accepted Apellis’ unsolicited major amendment to the new ...

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BioMarin announces incremental progress on biologics license application review for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A program

7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial. ...

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Kiwis with rare disorders want faster progress on 'life or death' health strategy

6 November 2022 - For Samantha Lenik, being diagnosed with Pompe​ disease after seven years of symptoms was a “double-edged ...

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