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RSS FeedPosted by Michael Wonder on 16 May 2022
Travere Therapeutics announces FDA acceptance and priority review of new drug application for sparsentan for the treatment of IgA nephropathy
16 May 2022 - PDUFA target action date of 17 November 2022. ...
Posted by Michael Wonder on 14 May 2022
Bridgebio Pharma sells rare pediatric disease priority review voucher for $110 million
13 May 2022 - Entered into a definitive agreement to sell the rare paediatric disease priority review voucher it obtained in ...
Posted by Michael Wonder on 13 May 2022
PolarityTE announces FDA regenerative medicine advanced therapy designation granted to SkinTE
13 May 2022 - PolarityTE today announced that the U.S. FDA granted a regenerative medicine advanced therapy designation to SkinTE under ...
Posted by Michael Wonder on 04 May 2022
Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial
4 May 2022 - First Phase 3 trial in this setting to show improved overall survival with an immunotherapy added ...
Posted by Michael Wonder on 28 Apr 2022
FDA grants BTX 1801 new qualified infectious disease product designation status
28 April 2022 - With the recent completion of additional animal studies, the Phase 2 clinical study for BTX 1801 ...
Posted by Michael Wonder on 27 Apr 2022
Editas Medicine receives FDA rare paediatric disease designation for EDIT-301 for the treatment of beta thalassaemia
26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...
Posted by Michael Wonder on 25 Apr 2022
FDA grants regenerative medicine advanced therapy designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 25 Apr 2022
Tremelimumab accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi
25 April 2022 - STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted by Michael Wonder on 19 Apr 2022
Enhertu granted priority review in the U.S. for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer
19 April 2022 - Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a 54.9% tumour response ...
Posted by Michael Wonder on 12 Apr 2022
FDA grants Direct Biologics regenerative medicine advanced therapy designation for the use of ExoFlo in COVID-19 related ARDS
12 April 2022 - Direct Biologics announced that the U.S. FDA has awarded their EV drug product ExoFlo with a regenerative ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 04 Apr 2022
FDA accepts Dupixent (dupilumab) for priority review in patients aged 12 years and older with eosinophilic oesophagitis
4 April 2022 - If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis. ...
Posted by Michael Wonder on 30 Mar 2022
U.S. FDA accepts for priority review Taiho Oncology's new drug application for futibatinib for cholangiocarcinoma
30 March 2022 - Taiho Oncology and Taiho Pharmaceutical announced today that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...