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RSS FeedPosted by Michael Wonder on 01 May 2020
U.S. FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukaemia
1 May 2020 - Application based on results from the Phase 3 QUAZAR-AML-001 study. ...
Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...
Posted by Michael Wonder on 17 Apr 2020
FDA accepts for priority review biologics license application for REGN-EB3 to treat Ebola
16 April 2020 - REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy. ...
Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who ...
Posted by Michael Wonder on 01 Apr 2020
GW Pharmaceuticals and Greenwich Biosciences announce FDA acceptance of sNDA filing with priority review for Epidiolex (cannabidiol) in the treatment of seizures associated with tuberous sclerosis complex
31 March 2020 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 01 Apr 2020
FDA accepts Mesoblast's biologics licence application for Ryoncil and agrees to priority review
1 April 2020 - Mesoblast today announced that the United States FDA has accepted for priority review the Company’s biologics license ...
Posted by Michael Wonder on 12 Mar 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection was granted priority review by the U.S. FDA
11 March 2020 - RadioMedix and its commercial partner Curium announced the U.S. FDA has granted copper Cu 64 dotatate injection ...
Posted by Michael Wonder on 08 Mar 2020
Acacia Pharmaceuticals and Neuren Pharmaceuticals announce rare paediatric disease designation for trofinetide for the treatment of Rett syndrome
3 March 2020 - With no approved treatments in Rett syndrome, FDA decision highlights significant unmet need. ...
Posted by Michael Wonder on 03 Mar 2020
FDA grants rare paediatric disease designation to Stealth BioTherapeutics for elamipretide for the treatment of Barth syndrome
3 March 2020 - Stealth BioTherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for elamipretide ...
Posted by Michael Wonder on 28 Feb 2020
Tessa Therapeutics announces U.S. FDA regenerative medicine advanced therapy designation granted to its CD30 CAR-T cell therapy for the treatment of relapsed or refractory CD30-positive classical Hodgkin lymphoma
27 February 2020 - RMAT designation follows positive proof-of-concept data from two independent Phase I/II clinical studies conducted by Baylor College ...
Posted by Michael Wonder on 19 Feb 2020
U.S. FDA accepts Karyopharm’s supplemental new drug application for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B cell lymphoma
19 February 2020 - Priority review granted; user fee goal date set for 23 June 2020. ...
Posted by Michael Wonder on 19 Feb 2020
FDA grants priority review to Genentech’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer
18 February 2020 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 18 Feb 2020
Vifor Pharma acquires priority review voucher
17 February 2020 - Vifor Pharma today announced that it has agreed to purchase a US FDA priority review voucher. ...
Posted by Michael Wonder on 18 Feb 2020
PharmaMar and Jazz Pharmaceuticals announce FDA acceptance and priority review of new drug application for lurbinectedin in relapsed small cell lung cancer
17 February 2020 - Prescription Drug User Fee Act date set for 16 August 2020. ...
Posted by Michael Wonder on 14 Feb 2020
Epizyme announces FDA acceptance of new drug application for filing with priority review for Tazverik (tazemetostat) for the treatment of follicular lymphoma
14 February 2020 - Approval would expand Tazverik label into second indication. ...