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RSS FeedPosted by Michael Wonder on 09 May 2017
FDA grants fast track designation to XyloCor Therapeutics lead candidate XC001
8 May 2017 - XyloCor Therapeutics announced that the U.S. FDA has granted fast track designation to its lead product candidate ...
Posted by Michael Wonder on 09 May 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for Alzheimer’s disease agitation
8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation ...
Posted by Michael Wonder on 05 May 2017
Sangamo Therapeutics announces special regulatory designations from the FDA for three clinical programs
4 May 2017 - Fast track designation for SB-FIX in vivo genome editing treatment for haemophilia B. ...
Posted by Michael Wonder on 03 May 2017
Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz (tofacitinib citrate) for the treatment of adult patients with active psoriatic arthritis
3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for ...
Posted by Michael Wonder on 02 May 2017
Atlantic Healthcare initiates FDA rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
1 May 2017 - Filing of the nonclinical package marks a key milestone in the process towards obtaining marketing approval ...
Posted by Michael Wonder on 26 Apr 2017
Lilly gives no time frame on arthritis drug delay; shares fall
25 April 2017 - Eli Lilly said Tuesday provided no new information on how long U.S. regulators might delay approval ...
Posted by Michael Wonder on 25 Apr 2017
Epizyme announces tazemetostat fast track designation for follicular lymphoma and plenary session on Phase 2 NHL data at ICML
25 April 2017 - Interim efficacy and safety data from ongoing Phase 2 study in follicular lymphoma and DLBCL selected for ...
Posted by Michael Wonder on 19 Apr 2017
Egalet announces U.S. FDA acceptance of file for prior approval supplement for Oxaydo (oxycodone hydrochloride) tablets 10 mg and 15 mg dosage strengths
18 April 2017 - FDA goal date is 17 June 2017. ...
Posted by Michael Wonder on 17 Apr 2017
AMAG submits supplemental new drug application to FDA for Makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use
17 April 2017 - FDA decision anticipated on supplemental new drug application filing in the fourth quarter 2017. ...
Posted by Michael Wonder on 14 Apr 2017
Relmada announces FDA fast track designation for d-methadone for adjunctive treatment of major depressive disorder
13 April 2017 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation for d-Methadone (REL-1017, dextromethadone), ...
Posted by Michael Wonder on 07 Apr 2017
Innocrin Pharmaceuticals granted fast track designation by FDA for seviteronel treatment of women with triple-negative breast cancer and women or men with estrogen receptor-positive breast cancer
6 April 2017 - Innocrin has announced that the FDA granted a second fast track designation for seviteronel (VT-464). ...
Posted by Michael Wonder on 06 Apr 2017
Prometic completes the filing of its plasminogen biologics license application with the U.S. FDA
5 April 2017 - Prometic Life Sciences announced today that it has completed the filing of its plasminogen biologics license ...
Posted by Michael Wonder on 04 Apr 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated dMMR or MSI-H metastatic colorectal cancer
4 April 2017 - Application based on results from Phase 2 CheckMate-142 study. ...
Posted by Michael Wonder on 04 Apr 2017
AbbVie announces Ibrutinib (Imbruvica) supplemental new drug application for previously treated chronic graft-versus-host-disease accepted for review by U.S. FDA
4 April 2017 - AbbVie today announced a supplemental new drug application was accepted for review by the U.S. FDA for ...
Posted by Michael Wonder on 04 Apr 2017
Jazz Pharmaceuticals completes rolling submission of new drug application for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia
3 April 2017 - Jazz Pharmaceuticals today announced the completion on 31 March 2017 of a rolling submission of a new ...