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RSS FeedPosted by Michael Wonder on 21 Jan 2020
US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. ...
Posted by Michael Wonder on 20 Jan 2020
Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer
20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected ...
Posted by Michael Wonder on 17 Jan 2020
Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease
16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...
Posted by Michael Wonder on 15 Jan 2020
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer
15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...
Posted by Michael Wonder on 15 Jan 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer
15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...
Posted by Michael Wonder on 13 Jan 2020
Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer
13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...
Posted by Michael Wonder on 09 Jan 2020
Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease
8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...
Posted 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 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...
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 17 Dec 2019
Rocket Pharmaceuticals receives EMA PRIME eligibility for RP-L102 gene therapy for Fanconi anaemia
16 December 2019 - Milestone gives Fanconi anaemia program all accelerated regulatory tools in U.S. and EU, including FDA regenerative medicine ...
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 04 Dec 2019
Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain
3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...
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 ...