11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...
11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United ...
8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC. ...
8 May 2017 - XyloCor Therapeutics announced that the U.S. FDA has granted fast track designation to its lead product candidate ...
8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation ...
4 May 2017 - Fast track designation for SB-FIX in vivo genome editing treatment for haemophilia B. ...
3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for ...
1 May 2017 - Filing of the nonclinical package marks a key milestone in the process towards obtaining marketing approval ...
1 May 2017 - Company’s primary development focus is non-covalent reversible BTK inhibitor SNS-062. ...
26 April 2017 - Kiadis Pharma today announces it has submitted a marketing authorisation application to the EMA for its ...
25 April 2017 - Eli Lilly said Tuesday provided no new information on how long U.S. regulators might delay approval ...
25 April 2017 - Orexigen Therapeutics today announced that Health Canada has completed its screening phase and accepted for review ...
25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...
25 April 2017 - Interim efficacy and safety data from ongoing Phase 2 study in follicular lymphoma and DLBCL selected for ...
25 April 2017 - On 18 January 2017, Sandoz officially notified the CHMP that it wishes to withdraw its application ...