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RSS FeedPosted by Michael Wonder on 30 Nov 2017
Adamis Pharmaceuticals submits prior approval supplement to FDA for the paediatric version of Symjepi
29 November 2017 - Adamis Pharmaceuticals today announced the submission of a prior approval supplement to the U.S. FDA for ...
Posted by Michael Wonder on 29 Nov 2017
Pharming submits supplemental biologics license application to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
27 November 2017 - Submission based on positive results from two clinical trials. ...
Posted by Michael Wonder on 29 Nov 2017
GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria
29 November 2017 - Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases. ...
Posted by Michael Wonder on 28 Nov 2017
Dova Pharmaceuticals announces FDA acceptance of the avatrombopag new drug application with priority review
27 November 2017 - Dova Pharmaceuticals today announced the new drug application for avatrombopag has been accepted for filing and has ...
Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 23 Nov 2017
Alkermes’ new drug application for investigational product designed for initiation onto Aristada accepted for filing by U.S. FDA
16 November 2017 - FDA action expected by 30 June 2018. ...
Posted by Michael Wonder on 23 Nov 2017
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
23 November 2017 - GlaxoSmithKline and Innoviva today announced the filing of a supplemental new drug application with the US FDA ...
Posted by Michael Wonder on 22 Nov 2017
U.S. FDA accepts regulatory submission and grants priority review for US WorldMeds' lofexidine
21 November 2017 - US WorldMeds today announced that the U.S. FDA has accepted and granted priority review of the ...
Posted by Michael Wonder on 21 Nov 2017
NDA submission for VivaGel BV in the US
21 November 2017 - Starpharma today announced that its US new drug application submission for VivaGel BV for both treatment ...
Posted by Michael Wonder on 21 Nov 2017
Janssen submits application to U.S. FDA to expand indication for Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
21 November 2017 - Supplemental biologics license application seeks first indication for Darzalex for the treatment of newly diagnosed patients. ...
Posted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 17 Nov 2017
Alnylam initiates rolling submission of new drug application to U.S. FDA for patisiran for the treatment of hereditary ATTR amyloidosis
16 November 2017 - Company plans to complete submission by year end. ...
Posted by Michael Wonder on 16 Nov 2017
Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS
15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
Posted by Michael Wonder on 14 Nov 2017
Theratechnologies announces decision by the FDA to extend the ibalizumab review period to 3 April 2018
13 November 2017 - Theratechnologies announced that it was notified today by its partner, TaiMed Biologics that the U.S. FDA ...
Posted by Michael Wonder on 13 Nov 2017
Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
13 November 2017 - Filing supported by positive results from two pivotal Phase 3 efficacy studies and one 12 month ...