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RSS FeedPosted by Michael Wonder on 05 Nov 2017
Progenics Pharmaceuticals completes submission of NDA for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
2 November 2017 - Progenics Pharmaceuticals announced today that it has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 01 Nov 2017
GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
30 October 2017 - GW Pharmaceuticals today announced it has completed the rolling submission of a new drug application to ...
Posted by Michael Wonder on 01 Nov 2017
Bayer announces BAY94-9027 biologics license application accepted by U.S. Food & Drug Administration
30 October 2017 - The U.S. FDA has accepted Bayer's biologics license application filing for BAY94-9027, an extended half-life site-specifically PEGylated ...
Posted by Michael Wonder on 31 Oct 2017
Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including ...
Posted by Michael Wonder on 28 Oct 2017
Achaogen submits plazomicin new drug application to the U.S. FDA for treatment of complicated urinary tract infections and bloodstream infections
26 October 2017 - Investigational drug has potential to treat certain multi-drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae. ...
Posted by Michael Wonder on 28 Oct 2017
AbbVie receives U.S. FDA priority review for investigational oral treatment elagolix for the management of endometriosis with associated pain
27 October 2017 - If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain ...
Posted by Michael Wonder on 27 Oct 2017
FDA accepts Genentech’s supplemental biologics license application for Avastin as a front-line treatment for women with advanced ovarian cancer
25 October 2017 - Genentech announced today that the U.S. FDA has accepted the company's supplemental biologics license application for ...
Posted by Michael Wonder on 26 Oct 2017
PTC Therapeutics receives complete response letter for ataluren's NDA
25 October 2017 - PTC Therapeutics today announced that the Office of Drug Evaluation I of the U.S. FDA has ...
Posted by Michael Wonder on 19 Oct 2017
Teva announces submission of biologics license application for fremanezumab to the U.S. FDA
17 October 2017 - Key milestone reached for Teva to advance global fremanezumab program for the preventive treatment of migraine. ...
Posted by Michael Wonder on 16 Oct 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review
16 October 2017 - Application based on results from Phase 3 CheckMate-238 study. ...
Posted by Michael Wonder on 14 Oct 2017
Prometic announces FDA acceptance of its biologics license application for plasminogen (Ryplazim)
13 October 2017 - Ryplazim previously granted fast track, rare paediatric disease and orphan drug designations by U.S. FDA. ...
Posted by Michael Wonder on 12 Oct 2017
AcelRx Pharmaceuticals receives complete response letter from the FDA for Dsuvia NDA
12 October 2017 - AcelRx Pharmaceuticals today announced that it received a complete response letter from the U.S FDA regarding its ...
Posted by Michael Wonder on 12 Oct 2017
FDA grants priority review for potential new indication for Lilly's Verzenio (abemaciclib) as initial treatment of advanced breast cancer
12 October 2017 - Eli Lilly and Company today announced that the U.S. FDA has granted priority review designation for its ...
Posted by Michael Wonder on 12 Oct 2017
Janssen submits new drug application to U.S. FDA for apalutamide (ARN-509) to treat men with non-metastatic castration-resistant prostate cancer
11 October 2017 - First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk ...
Posted by Michael Wonder on 12 Oct 2017
U.S. FDA accepts for review Astellas’ supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
12 September 2017 - If approved, the combination therapy could potentially offer a new treatment option for patients whose overactive ...