22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing ...
15 August 2018 - Data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages 12 to <24 months. ...
8 August 2018 - Applications seek to update prescribing information and summary of product characteristics. ...
2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...
7 June 2018 - U.S. new drug application granted FDA priority review. ...
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
2 March 2018 - Patient safety is the top priority for Biogen and AbbVie. ...
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
12 February 2018 - U.S. new drug application granted FDA priority review. ...
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...