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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Apellis announces plans to submit 24 month Phase 3 data to the FDA for pegcetacoplan NDA for geographic atrophy

3 November 2022 - Submission will be a major amendment to the new drug application, extending the review period by ...

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US FDA defers action on filing for AT-GAA in late-onset Pompe disease

28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing ...

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US FDA delays panel meet on Perrigo's OTC birth control pill

26 October 2022 - The US FDA has delayed a meeting of its advisory panel to discuss Perrigo's over the ...

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IntelGenx receives FDA GDUFA date for Xiromed partnered development candidate, buprenorphine buccal film

25 October 2022 - IntelGenx today announced that its previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated ...

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Hugel Aesthetics receives FDA acceptance of BLA resubmission for letibotulinumtoxinA for injection for glabellar lines

25 October 2022 - PDUFA goal date set for 6 April 2023. ...

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Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen

17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...

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Cystic fibrosis: Rotorua mother gives PHARMAC a year to fund Trikafta before moving overseas

13 October 2022 - A desperate Rotorua mother has been told by her doctor to consider getting a lung transplant ...

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Monkeypox vaccine not expected in NZ until December as community spread confirmed

10 October 2022 - New Zealand now has community transmission of monkeypox, but a vaccine to protect those at highest ...

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Split Real Time Application Review (STAR)

3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...

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