Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...
Posted by Michael Wonder on 21 Jun 2017
Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients
19 June 2017 - Takeda and TiGenix today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for ...
Posted by Michael Wonder on 20 Jun 2017
FDA grants fast track designation to Axovant's nelotanserin for visual hallucinations in dementia with Lewy bodies
19 June 2017 - Axovant Sciences today announced that the U.S. FDA has granted fast track designation to its investigational ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...
Posted by Michael Wonder on 15 Jun 2017
Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba label
14 June 2017 - Novo Nordisk today announced the submission of a type II variation application to the EMA for including ...
Posted by Michael Wonder on 07 Jun 2017
Pfizer receives FDA fast track designation for tafimidis for transthyretin cardiomyopathy
6 June 2017 - Tafamidis, an investigational medicine for TTR-CM a rare, progressive and fatal disease, is currently in phase ...
Posted by Michael Wonder on 06 Jun 2017
BioCryst announces Rapivab paediatric sNDA acceptance
5 June 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 05 Jun 2017
Deadline approaching
5 June 2017 - Final date close for submissions to controversial drug post-marketing review. ...
Posted by Michael Wonder on 05 Jun 2017
Amgen submits regulatory applications for Repatha (evolocumab) cardiovascular outcomes data in US and Europe
5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a ...
Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...
Posted by Michael Wonder on 03 Jun 2017
Pfizer announces acceptance of regulatory submissions by U.S. FDA and EMA for Sutent (sunitinib) for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgery
31 May 2017 - Applications seek to expand approved use of Sutent based on data from the Phase 3 S-TRAC trial. ...
Posted by Michael Wonder on 01 Jun 2017
Novo Nordisk receives US FDA approval of Rebinyn (nonacog beta pegol; N9-GP)
31 May 2017 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Rebinyn ...
Posted by Michael Wonder on 01 Jun 2017
Nicox receives FDA approval of Zerviate (cetirizine ophthalmic solution) 0.24%
31 May 2017 - U.S. patent protection until at least 2030. ...
Posted by Michael Wonder on 01 Jun 2017
Jazz Pharmaceuticals announces FDA acceptance of NDA for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia, with priority review status
31 May 2017 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...