Blog
RSS FeedPosted by Michael Wonder on 27 Mar 2019
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
26 March 2019 - Submission based on data from Phase III CASSIOPEIA study. ...
Posted by Michael Wonder on 26 Mar 2019
Celgene submits application to FDA for ozanimod for the treatment of relapsing forms of multiple sclerosis
25 March 2019 - Celgene Corporation today announced that the Company has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 20 Mar 2019
Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic
20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 18 Mar 2019
U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy
18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition. ...
Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA. ...
Posted by Michael Wonder on 15 Mar 2019
Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)
15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for ...
Posted by Michael Wonder on 15 Mar 2019
Eton Pharmaceuticals submits new drug application for DS-200
14 March 2019 - FDA previously granted DS-200 fast track designation. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...
Posted by Michael Wonder on 13 Mar 2019
Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...
Posted by Michael Wonder on 11 Mar 2019
Eisai and Imbrium Therapeutics announce U.S. FDA filing acceptance of new drug application for lemborexant for the treatment of insomnia
11 March 2019 - Eisai Co and Imbrium Therapeutics today announced that the U.S. FDA has accepted for review the ...
Posted by Michael Wonder on 11 Mar 2019
Allergan announces FDA acceptance of new drug application for ubrogepant for the acute treatment of migraine
11 March 2019 - Ubrogepant seeks to be the first oral calcitonin gene-related peptide receptor antagonist for the acute treatment of ...
Posted by Michael Wonder on 11 Mar 2019
TB medicine pretomanid enters regulatory review process in the United States
8 March 2019 - TB Alliance’s new drug application for the novel tuberculosis drug candidate pretomanid has been accepted for ...
Posted by Michael Wonder on 09 Mar 2019
Foamix announces FDA acceptance of new drug application for FMX101 minocycline foam for the treatment of moderate-to-severe acne
7 March 2019 - PDUFA target action date of 20 October 2019. ...