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RSS FeedPosted by Michael Wonder on 27 Jan 2022
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 ...
Posted by Michael Wonder on 26 Jan 2022
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 ...
Posted by Michael Wonder on 24 Jan 2022
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 ...
Posted by Michael Wonder on 17 Jan 2022
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 ...
Posted by Michael Wonder on 13 Jan 2022
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 ...
Posted by Michael Wonder on 11 Jan 2022
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 ...
Posted by Michael Wonder on 05 Jan 2022
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 ...
Posted by Michael Wonder on 04 Jan 2022
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. ...
Posted by Michael Wonder on 31 Dec 2021
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 ...
Posted by Michael Wonder on 22 Dec 2021
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 ...
Posted by Michael Wonder on 18 Dec 2021
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, ...
Posted by Michael Wonder on 16 Dec 2021
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 ...
Posted by Michael Wonder on 15 Dec 2021
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. ...
Posted by Michael Wonder on 15 Dec 2021
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 ...
Posted by Michael Wonder on 30 Nov 2021
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. ...