Blog
RSS FeedPosted by Michael Wonder on 13 Mar 2017
Novartis Kisqali (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor
13 March 2017 - Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival ...
Posted by Michael Wonder on 13 Mar 2017
Rare diseases patients need more than miracles and Trumpcare
11 March 2017 - Never one to miss an opportunity, Trump cheapened Rare Disease Week by exploiting a young woman, Megan ...
Posted by Michael Wonder on 11 Mar 2017
Radius Health receives notification of PDUFA extension for abaloparatide
10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017. ...
Posted by Michael Wonder on 11 Mar 2017
Trump picks Scott Gottlieb to serve as FDA Commissioner
11 March 2017 - Nominee was senior FDA executive under George W. Bush. ...
Posted by Michael Wonder on 10 Mar 2017
Keryx Biopharmaceuticals announces U.S. FDA filing acceptance of supplemental new drug application for Auryxia (ferric citrate) tablets
8 March 2017 - Keryx Biopharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 10 Mar 2017
Nicox resubmits AC-170 (Zerviate) NDA to the U.S. FDA
9 March 2017 - CGMP issues at the API manufacturer have been resolved. ...
Posted by Michael Wonder on 09 Mar 2017
Few people actually benefit from ‘breakthrough’ cancer immunotherapy
8 March 2017 - People with cancer face many challenges, including the symptoms of the disease, the toxicity of the ...
Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase ...
Posted by Michael Wonder on 09 Mar 2017
PTC Therapeutics announces FDA acknowledgment of new drug application filing for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
6 March 2017 - FDA has assigned a PDUFA date of 24 October 2017. ...
Posted by Michael Wonder on 08 Mar 2017
FDA accepts supplemental new drug application for Vraylar (cariprazine)
8 March 2017 - Application seeks to expand Vraylar label to include phase 3 clinical data for the maintenance treatment ...
Posted by Michael Wonder on 07 Mar 2017
FDA grants fast track designation for Mesoblast's cell therapy in children with acute graft versus host disease
7 March 2017 - Mesoblast today announced that the US FDA has granted a fast track designation for the use of ...
Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin. ...
Posted by Michael Wonder on 04 Mar 2017
GAO: drug makers want more clarity on antibiotic incentives
3 March 2017 - Despite some improvements, drug makers say the US FDA has not fully clarified its expectations for ...
Posted by Michael Wonder on 03 Mar 2017
Trump calls the FDA ‘slow and burdensome,’ but it’s faster than ever
2 March 2017 - Two days before Christmas, the Food and Drug Administration gave Thomas Crawford an unexpected gift: approval ...
Posted by Michael Wonder on 03 Mar 2017
FDA approves first treatment for frequent urination at night due to overproduction of urine
3 March 2017 - The U.S. FDA today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two ...