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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Tonix Pharmaceuticals receives rare paediatric disease designation from the FDA for TNX-2900 for the treatment of Prader-Willi syndrome

25 March 2024 - TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and ...

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FDA grants Argenica rare paediatric disease designation for ARG-007 in the treatment of HIE

25 March 2024 - Argenica Therapeutics is pleased to announce the US FDA has granted its neuroprotective drug ARG-007 rare ...

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Lisata Therapeutics announces US FDA rare paediatric disease designation granted to LSTA1 for the treatment of osteosarcoma

21 March 2024 - Lisata Therapeutics today announced that the US FDA has granted rare paediatric disease designation to LSTA1, the ...

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Deverra Therapeutics granted FDA regenerative medicine advanced therapy and orphan drug designations for DVX101 (Dilanubicel) for the treatment of acute myeloid leukaemia

19 March 2024 - Deverra Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to its lead ...

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PepGen receives US FDA orphan drug and rare paediatric disease designations for PGN-EDO51 for the treatment of Duchenne muscular dystrophy

13 March 2024 - PepGen today announced that the US FDA granted both orphan drug and rare paediatric disease designations for ...

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Applied Therapeutics announces FDA acceptance and priority review of new drug application for govorestat for the treatment of classic galactosaemia

28 February 2024 - PDUFA target action date of 28 August 2024. ...

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Incyte announces US FDA grants priority review for axatilimab for the treatment of chronic graft versus host disease

27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...

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US FDA accepts for priority review the supplemental biologics license application for epcoritamab (Epkinly) for difficult to treat relapsed or refractory follicular lymphoma

26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...

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Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of COPD with type 2 inflammation

23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...

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US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy

21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...

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Avidity Biosciences receives FDA rare paediatric disease designation for AOC 1044 for treatment of Duchenne muscular dystrophy in people with mutations amenable to exon 44 skipping

20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...

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Linvoseltamab BLA for treatment of relapsed/refractory multiple myeloma accepted for FDA priority review

21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...

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argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy

20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...

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FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma

20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...

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