23 January 2017 - Novelion Therapeutics today announced that the EMA has accepted for review the marketing authorisation application for metreleptin ...
23 January 2017 - Ocular Therapeutix today announced that it has resubmitted a new drug application to the U.S. FDA for ...
19 January 2017 - Application follows recent FDA general advice letter supporting use of extrapolated data to assess monotherapy use ...
19 January 2017 - Shire announced that the U.S. FDA has acknowledged receipt of the Class 2 resubmission of a new ...
19 January 2017 - AusBiotech, supported by the AusMedtech Regulatory Affairs Expert Panel, has submitted to two medical device consultations ...
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
13 January 2017 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
12 January 2017 - If approved by the U.S. FDA, Cinvanti will strengthen Heron’s chemotherapy-induced nausea and vomiting franchise by ...
11 January 2017 - No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional ...
11 January 2017 - If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the U.S. ...
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression. ...
10 January 2017 - Abbvie was seeking funding for venetoclax when used as a treatment for patients with chronic lymphocytic ...
5 January 2017 - Melinta Therapeutics announced today the U.S. FDA has accepted the company’s new drug applications for IV ...
4 January 2017 - Application seeks to extend duration of use up to 4 years. ...
4 January 2017 - The PBAC considered 192 submissions in 2016; 193 were considered by the Committee in 2015. ...