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RSS FeedPosted by Michael Wonder on 06 Jan 2020
Farxiga granted FDA priority review for patients with heart failure with reduced ejection fraction
6 January 2020 - AstraZeneca today announced the US FDA has accepted a supplemental new drug application and granted Priority ...
Posted by Michael Wonder on 18 Dec 2019
Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA
18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...
Posted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...
Posted by Michael Wonder on 03 Dec 2019
Regenerative medicine advanced therapy designation granted by FDA to ADP‑A2M4 for the treatment of synovial sarcoma
3 December 2019 - Will enable expedited development and review of ADP-A2M4 with the goal of commercialisation in 2022 for patients ...
Posted by Michael Wonder on 02 Dec 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC)
2 December 2019 - Application based on results from Phase 2 KEYNOTE-057 trial, to be discussed at December FDA Oncologic Drugs ...
Posted by Michael Wonder on 30 Nov 2019
Imfinzi granted FDA priority review for the treatment of patients with extensive-stage small cell lung cancer
29 November 2019 - AstraZeneca today announced that the US FDA has accepted a supplemental biologics license application and granted ...
Posted by Michael Wonder on 28 Nov 2019
Incyte announces acceptance and priority review of NDA for pemigatinib as a treatment for patients with cholangiocarcinoma
27 November 2019 - Incyte today announced that the U.S. FDA has accepted for Priority Review its new drug application for ...
Posted by Michael Wonder on 26 Nov 2019
Phathom Pharmaceuticals provides corporate update
25 November 2019 - Received qualified infection disease pathogen designation from the U.S. FDA for vonoprazan in combination with both amoxicillin ...
Posted by Michael Wonder on 25 Nov 2019
FDA accepts Intercept’s new drug application for OCA for the treatment of liver fibrosis due to NASH and grants priority review
25 November 2019 - NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of ...
Posted by Michael Wonder on 25 Nov 2019
FDA grants priority review to Roche’s risdiplam for spinal muscular atrophy
25 November 2019 - Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people ...
Posted by Michael Wonder on 20 Nov 2019
Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome
19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...
Posted by Michael Wonder on 14 Nov 2019
Anavex Life Sciences receives rare paediatric disease designation from FDA for Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome
14 November 2019 - Anavex Life Sciences today announced that it received the rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Nov 2019
US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review
14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...
Posted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...
Posted by Michael Wonder on 28 Oct 2019
CARsgen announces investigational CAR-T therapy CT053 granted RMAT designation by the U.S. FDA for relapsed/refractory multiple myeloma
28 October 2019 - CARsgen Therapeutics today announced that the United States FDA has granted regenerative medicine advanced therapy designation to ...