Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2018
AbbVie submits biologics license application to U.S. FDA for investigational treatment risankizumab for moderate to severe plaque psoriasis
25 April 2018 - The biologics license application is supported by four Phase 3 studies of more than 2,000 patients with ...
Posted by Michael Wonder on 24 Apr 2018
FDA accepts Veloxis's supplemental new drug application for the de novo indication for Envarsus XR
19 April 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA has accepted for standard review the Company's supplemental ...
Posted by Michael Wonder on 24 Apr 2018
FDA Advisory Committee recommends the approval of baricitinib 2 mg, but not 4 mg, for the treatment of moderately-to-severely active rheumatoid arthritis
23 April 2018 - Eli Lilly and Incyte Corporation announced today that the U.S. FDA Arthritis Advisory Committee recommended approval of ...
Posted by Michael Wonder on 23 Apr 2018
Sage Therapeutics submits new drug application to U.S. FDA for intravenous brexanolone in the treatment of post-partum depression
23 April 2018 - Brexanolone IV submission is the company’s first new drug application. ...
Posted by Michael Wonder on 16 Apr 2018
Alkermes announces FDA acceptance for review of new drug application for ALKS 5461 for the adjunctive treatment of major depressive disorder
16 April 2018 - FDA action expected by 31 January 2019. ...
Posted by Michael Wonder on 16 Apr 2018
Eagle Pharmaceuticals’ vasopressin ANDA accepted for filing by the FDA
16 April 2018 - Eagle Pharmaceuticals today announced that it has submitted and the U.S. FDA has accepted for filing ...
Posted by Michael Wonder on 10 Apr 2018
AbbVie and Neurocrine Biosciences announce PDUFA target date of Q3 2018 for elagolix in endometriosis-associated pain
10 April 2018 - FDA requires extended time for review of additional information in new drug application. ...
Posted by Michael Wonder on 09 Apr 2018
FDA accepts new drug application for duvelisib and grants priority review
9 April 2018 - Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic ...
Posted by Michael Wonder on 07 Apr 2018
FDA rejects Teva/Celltrion biosimilars
6 April 2018 - Teva and Celltrion’s attempt to muscle in on the multi-billion dollar US cancer and inflammatory disease ...
Posted by Michael Wonder on 06 Apr 2018
Antares Pharma provides Xyosted regulatory update
5 April 2018 - Complete response resubmission accepted – PDUFA date 29 September 2018. ...
Posted by Michael Wonder on 06 Apr 2018
Stemline Therapeutics announces start of rolling BLA submission for SL-401
5 April 2018 - Stemline Therapeutics announced today that it has initiated its rolling submission of a biologics license application for ...
Posted by Michael Wonder on 04 Apr 2018
Paratek’s new drug applications for oral and intravenous omadacycline accepted for priority review by FDA
4 April 2018 - PDUFA action date in October 2018. ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 04 Apr 2018
Motif Bio initiates NDA rolling submission for iclaprim
3 April 2018 - Motif Bio today announced the initiation of a rolling submission of a new drug application to ...
Posted by Michael Wonder on 03 Apr 2018
US FDA accepts biologics license application for moxetumomab pasudotox in hairy cell leukaemia
3 April 2018 - Moxetumomab pasudotox application granted priority review. ...