Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 22 Mar 2022
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted rare paediatric disease designation by the US FDA for the treatment of neuroblastoma
21 March 2022 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a rare paediatric disease ...
Posted by Michael Wonder on 07 Mar 2022
Horizon Therapeutics announces FDA has granted priority review of the supplemental biologics license application for the concomitant use of Krystexxa (pegloticase injection) plus methotrexate for people living with uncontrolled gout
7 March 2022 - Application based on recent MIRROR randomised controlled trial results, which showed 71% of patients randomised to ...
Posted by Michael Wonder on 07 Mar 2022
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with previously untreated IDH1 mutated acute myeloid leukaemia
7 March 2022 - sNDA based on data from the global, Phase 3, AGILE trial evaluating Tibsovo in combination with ...
Posted by Michael Wonder on 02 Mar 2022
Advanced Innovative Partners announces designation for rare paediatric disease drug
1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...
Posted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...