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RSS FeedPosted 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. ...
Posted by Michael Wonder on 15 Feb 2019
FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices
14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...
Posted by Michael Wonder on 14 Feb 2019
Motif Bio receives complete response letter from the FDA
14 February 2019 - Motif Bio announced today that the Company has received a complete response letter from the U.S. FDA ...
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. ...