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RSS FeedPosted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...
Posted by Michael Wonder on 19 Feb 2019
Pfenex announces FDA acceptance of NDA for PF708
19 February 2019 - FDA sets PDUFA date of 7 October 2019. ...
Posted by Michael Wonder on 19 Feb 2019
FDA grants priority review to Roche’s personalised medicine entrectinib
19 February 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug ...
Posted 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
OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer
23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...
Posted by Michael Wonder on 16 Feb 2019
Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer
12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...
Posted by Michael Wonder on 16 Feb 2019
Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint
24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...
Posted by Michael Wonder on 16 Feb 2019
Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer
6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...
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
CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis
15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for ...
Posted by Michael Wonder on 15 Feb 2019
FDA advances new efforts to promote development of safe and effective regenerative medicine products
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
Posted by Michael Wonder on 15 Feb 2019
Statement from FDA Commissioner on new policy to improve access and foster price competition for drugs that face inadequate generic competition
15 February 2019 - In too many cases, branded drugs that are no longer protected by patents or other exclusivities ...
Posted by Michael Wonder on 15 Feb 2019
RDD Pharma receives fast track designation from FDA for RDD-0315 for treatment of faecal incontinence in spinal cord injury patients
14 February 2019 - RDD Pharma announced today that the U.S. FDA granted fast track status for RDD-0315 for the treatment ...
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. ...