Blog
RSS FeedPosted by Michael Wonder on 07 Apr 2020
Mallinckrodt initiates rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
6 April 2020 - Application is supported by data from pivotal phase 3 study for the treatment of deep partial-thickness thermal ...
Posted by Michael Wonder on 03 Apr 2020
Zealand Pharma submits new drug application to the U.S. FDA for the dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia
31 March 2020 - The dasiglucagon HypoPal Rescue Pen new drug application represents a major milestone in Zealand Pharma’s efforts to ...
Posted by Michael Wonder on 02 Apr 2020
Y-mAbs announces submission of naxitamab biologics license application to U.S. FDA
1 April 2020 - Y-mAbs Therapeutics today announced that the Company has completed the submission of its biologics license application under ...
Posted by Michael Wonder on 01 Apr 2020
Rhythm Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for setmelanotide in POMC and LEPR deficiency obesities
30 March 2020 - Rhythm Pharmaceuticals today announced that it has completed its rolling submission of a new drug application to ...
Posted by Michael Wonder on 01 Apr 2020
Aveo Oncology announces submission of new drug application to U.S. FDA for tivozanib in patients with relapsed or refractory renal cell carcinoma
31 March 2020 - Aveo Oncology today announced that it has submitted a new drug application to the U.S. FDA for ...
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 31 Mar 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (Ide-cel, bb2121) to FDA
31 March 2020 - Submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient ...
Posted by Michael Wonder on 30 Mar 2020
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis
30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...
Posted by Michael Wonder on 29 Mar 2020
IntelGenx receives complete response letter from FDA for Rizaport NDA
27 March 2020 - IntelGenx today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 26 Mar 2020
Jazz Pharmaceuticals announces FDA acceptance of new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy
25 March 2020 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for filing with priority review the company's new ...
Posted by Michael Wonder on 23 Mar 2020
Eiger BioPharmaceuticals completes submission of new drug application to FDA for lonafarnib for treatment of progeria and progeroid laminopathies
23 March 2020 - Progeria MAA submitted to EMA and granted accelerated assessment. ...
Posted by Michael Wonder on 20 Mar 2020
Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response
20 March 2020 - Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of ...
Posted by Michael Wonder on 20 Mar 2020
US FDA issues complete response letter for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes
20 March 2020 - The U.S. FDA has issued a complete response letter for the supplemental new drug application of ...
Posted by Michael Wonder on 19 Mar 2020
Janssen submits ponesimod new drug application to the U.S. FDA for treatment of adults with relapsing multiple sclerosis
19 March 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA for ponesimod ...
Posted by Michael Wonder on 18 Mar 2020
DBV Technologies provides update on Viaskin Peanut BLA for children ages 4-11 years
16 March 2020 - DBV Technologies today announced that the U.S. FDA has informed the Company that during its ongoing review ...