Blog
RSS FeedPosted by Michael Wonder on 15 Jan 2019
Nabriva Therapeutics provides update on PDUFA date for intravenous Contepo
14 January 2019 - PDUFA action date now set for 30 April 2019. ...
Posted by Michael Wonder on 14 Jan 2019
US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy
14 January 2019 - FDA grants a priority review based on Phase 3 ATTR-ACT study findings. ...
Posted by Michael Wonder on 11 Jan 2019
US FDA sets PDUFA date for Scenesse
10 January 2019 - FDA does not plan to hold advisory committee meeting. ...
Posted by Michael Wonder on 01 Jan 2019
FDA grants priority review designation for Heron Therapeutics' NDA for HTX-011, a non-opioid for post-operative pain management
31 December 2018 - FDA not currently planning advisory Committee Meeting for NDA. ...
Posted by Michael Wonder on 23 Dec 2018
Bavarian Nordic announces FDA acceptance and priority review of biologics license application for MVA-BN smallpox vaccine
21 December 2018 - Bavarian Nordic today announced that the U.S. FDA has accepted its Biologics License Application (BLA) for the ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants priority review to Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
4 December 2018 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 03 Dec 2018
Novartis announces FDA filing acceptance and priority review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
3 December 2018 - The AVXS-101, now known as Zolgensma (onasemnogene abeparvovec-xxxx), filing is supported by data from the START trial ...
Posted by Michael Wonder on 28 Nov 2018
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy and fast track designations for RP-L102 gene therapy for Fanconi anaemia
27 November 2018 - Global trial of RP-L102 utilising no conditioning and “Process B” on track for early 2019. ...
Posted by Michael Wonder on 22 Nov 2018
FDA grants priority review for Daiichi Sankyo’s new drug application for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
22 November 2018 - Quizartinib marketing applications now under expedited review in the U.S., Japan and EU. ...
Posted by Michael Wonder on 21 Nov 2018
ImmunoMolecular Therapeutics awarded SBIR grant and receives rare paediatric disease designation from FDA for IMT-002
14 November 2018 - Rare paediatric disease designation granted to IMT-002 for type 1 diabetes. ...
Posted by Michael Wonder on 16 Nov 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
16 November 2018 - The U.S. FDA today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy ...
Posted by Michael Wonder on 13 Nov 2018
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
13 November 2018 - If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment ...
Posted by Michael Wonder on 12 Nov 2018
US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA mutated advanced ovarian cancer and grants priority review
12 November 2018 - First US regulatory submission acceptance for a PARP inhibitor as a first-line maintenance treatment for advanced ...
Posted by Michael Wonder on 09 Nov 2018
Lilly snaps up regulatory 'fast pass' for bargain price
2 November 2018 - Priority review vouchers used to be highly sought: back in 2015, for example, AbbVie paid United ...
Posted by Michael Wonder on 07 Nov 2018
FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate to severe atopic dermatitis
6 November 2018 - Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has accepted for priority review the ...