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RSS FeedPosted by Michael Wonder on 25 Jan 2017
Atlantic Healthcare receives FDA agreement to initiate rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
24 January 2017 - FDA to accept sections of the regulatory application ahead of final Phase 3 data expected in ...
Posted by Michael Wonder on 23 Jan 2017
Ocular Therapeutix resubmits NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery
23 January 2017 - Ocular Therapeutix today announced that it has resubmitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 22 Jan 2017
UCB files Briviact (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patients with partial-onset seizures
19 January 2017 - Application follows recent FDA general advice letter supporting use of extrapolated data to assess monotherapy use ...
Posted by Michael Wonder on 21 Jan 2017
U.S. FDA acknowledges receipt of Shire’s new drug application for SHP465 for ADHD
19 January 2017 - Shire announced that the U.S. FDA has acknowledged receipt of the Class 2 resubmission of a new ...
Posted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
Posted by Michael Wonder on 13 Jan 2017
U.S. FDA extends review period for baricitinib
13 January 2017 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
Posted by Michael Wonder on 13 Jan 2017
Heron announces submission of Cinvanti NDA for the prevention of chemotherapy-induced nausea and vomiting
12 January 2017 - If approved by the U.S. FDA, Cinvanti will strengthen Heron’s chemotherapy-induced nausea and vomiting franchise by ...
Posted by Michael Wonder on 13 Jan 2017
Tesaro receives complete response letter for rolapitant IV from U.S. FDA
11 January 2017 - No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional ...
Posted by Michael Wonder on 11 Jan 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar trastuzumab
11 January 2017 - If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the U.S. ...
Posted by Michael Wonder on 11 Jan 2017
Merck receives FDA acceptance of supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression. ...
Posted by Michael Wonder on 06 Jan 2017
Melinta Therapeutics’ new drug application for Baxdela accepted for filing by US FDA
5 January 2017 - Melinta Therapeutics announced today the U.S. FDA has accepted the company’s new drug applications for IV ...
Posted by Michael Wonder on 04 Jan 2017
FDA accepts for filing supplemental new drug application for Lilletta (levonorgestrel-releasing intrauterine system)
4 January 2017 - Application seeks to extend duration of use up to 4 years. ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular ...
Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. FDA seeking ...