Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour

24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...

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Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency

25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...

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Codexis announces FDA orphan drug and rare paediatric disease designations for CDX-6512 for the treatment of homocystinuria

24 January 2022 - Codexis today announced that the U.S. FDA has granted the company orphan drug designation for CDX-6512 for ...

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Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen

17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...

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CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting ...

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CARsgen announces CT041 CAR T-cell product candidate granted RMAT designation by the FDA

10 January 2022 - CARsgen Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CT041 for ...

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U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer

3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...

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Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis

3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022. ...

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Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS

29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...

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Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis

21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured ...

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bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor

17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...

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CSL Behring receives accelerated CHMP assessment for etranacogene dezaparvovec for European patients living with haemophilia B

15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...

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U.S. FDA grants priority review for spesolimab for the treatment of flares in patients with generalised pustular psoriasis, a rare, life-threatening skin disease

15 December 2021 - Additionally, FDA granted breakthrough therapy designation for spesolimab in the treatment of generalised pustular psoriasis flares. ...

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Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo

14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application ...

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Lynparza granted priority review in the US for BRCA mutated HER2 negative high risk early breast cancer

30 November 2021 - First medicine targeting BRCA mutations to show clinical benefit in adjuvant setting. ...

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