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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US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review

20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...

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Lykos Therapeutics announces FDA acceptance and priority review of new drug application for MDMA assisted therapy for PTSD

9 February 2024 - PDUFA date is 11 August 2024. ...

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GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk

6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...

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Valneva announces sale of priority review voucher for $103 million

5 February 2024 - Valneva today announced it sold the priority review voucher it received from the US FDA for ...

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Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome

5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...

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Tyra Biosciences receives FDA rare paediatric disease designation for TYRA-300 for the treatment of achondroplasia

1 February 2024 - Tyra Biosciences today announced that the US FDA has granted rare paediatric disease designation to TYRA-300, an ...

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Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review

31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...

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Enhertu granted priority review in the US for patients with metastatic HER2 positive solid tumours

29 January 2024 - Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. ...

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