PTC announces submission of sepiapterin MAA for treatment of PKU to EMA

28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...

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Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia

26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...

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Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia

26 March 2024 - PDUFA action date set for 26 September 2024. ...

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Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS

19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...

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US FDA approves Idorsia’s once-daily Tryvio (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives

20 March 2024 - Idorsia plans to make Tryvio available to the millions of patients in the US who are not ...

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Citius Pharmaceuticals announces FDA acceptance of the BLA resubmission of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma

18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024 ...

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Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis

11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...

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Travere Therapeutics submits supplemental new drug application to the US FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy

11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...

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Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot

11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...

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Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)

10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...

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Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma

6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...

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Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia

6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...

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Camurus announces FDA acceptance of NDA submission for Oclaiz for treatment of acromegaly

5 March 2024 - PDUFA set to 21 October 2024. ...

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CymaBay announces EMA accepts for review the marketing authorisation application for seladelpar for the treatment of primary biliary cholangitis

5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...

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Madrigal Pharmaceuticals announces EMA validation of its marketing authorisation application for resmetirom for the treatment of NASH/MASH with liver fibrosis

5 March 2024 - MAA submission is supported by positive results from MAESTRO-NASH, the only Phase 3 trial in NASH to ...

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