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RSS FeedPosted by Michael Wonder on 19 Feb 2019
AbbVie announces new drug application accepted for priority review by U.S. FDA for upadacitinib for treatment of moderate to severe rheumatoid arthritis
19 February 2019 - AbbVie used a priority review voucher to expedite review of the upadacitinib NDA. ...
Posted by Michael Wonder on 18 Feb 2019
Bausch Health provides update for Duobrii filing
15 February 2019 - Bausch Health announced that the U.S. FDA will be unable to meet today's Prescription Drug User Fee ...
Posted by Michael Wonder on 16 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma
15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial. ...
Posted by Michael Wonder on 15 Feb 2019
Sarepta announces FDA acceptance of golodirsen (SRP-4053) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 53
14 February 2019 - FDA grants priority review status. ...
Posted by Michael Wonder on 14 Feb 2019
Harmony Biosciences announces file acceptance of its new drug application for pitolisant
12 February 2019 - FDA grants priority review of the pitolisant new drug application. ...
Posted by Michael Wonder on 14 Feb 2019
DBV Technologies provides update on regulatory status of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age
13 February 2019 - Progress made to date to enable resubmission in Q3 2019. ...
Posted by Michael Wonder on 11 Feb 2019
FDA accepts sBLA and grants priority review for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
11 February 2019 - Merck and Pfizer today announced that the US FDA has accepted for priority review the supplemental biologics ...
Posted by Michael Wonder on 11 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
11 February 2019 - Filing includes use of Keytruda in the first-line setting as monotherapy or in combination with chemotherapy. ...
Posted by Michael Wonder on 07 Feb 2019
Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease
7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the ...
Posted by Michael Wonder on 05 Feb 2019
FDA accepts for review new drug application for Merck’s investigational combination of imipenem/cilastatin and relebactam, and supplemental NDA for Zerbaxa (ceftolozane and tazobactam)
5 February 2019 - Merck today announced that the U.S. FDA has accepted for review regulatory filings for two antibacterial ...
Posted by Michael Wonder on 05 Feb 2019
Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neo-adjuvant treatment
5 February 2019 - Roche’s application is being reviewed under the US FDA's real-time oncology review and Assessment Aid pilot programmes. ...
Posted by Michael Wonder on 05 Feb 2019
SK Life Science announces FDA acceptance of NDA submission for cenobamate, an investigational anti-epileptic drug
4 February 2019 - SK Life Science announced today that the U.S. FDA has accepted the filing of its new ...
Posted by Michael Wonder on 04 Feb 2019
Alkermes receives complete response letter from U.S. FDA for ALKS 5461 new drug application
1 February 2019 - Alkermes today announced that it received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 01 Feb 2019
AVEO Oncology announces NDA timing update
31 January 2019 - AVEO Oncology today announced that it has accepted the recommendation of the U.S. FDA not to ...