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RSS FeedPosted by Michael Wonder on 22 Feb 2017
Lead cancer immunotherapy candidate receives FDA fast track designation
21 February 2017 - Cell Medica today announced the U.S. FDA has granted fast rrack designation to its lead oncology ...
Posted by Michael Wonder on 22 Feb 2017
Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the U.S. FDA
21 February 2017 - Application requests approval for the treatment of relapsed or refractory acute lymphoblastic leukaemia in adults. ...
Posted by Michael Wonder on 21 Feb 2017
Vericel receives FDA fast track designation for ixmyelocel-T, an investigational product for the treatment of patients with advanced heart failure due to ischaemic dilated cardiomyopathy
21 February 2017 - Vericel Corporation today announced that the U.S. FDA has designated the investigation of ixmyelocel‑T for reduction ...
Posted by Michael Wonder on 21 Feb 2017
The Medicines Company announces FDA filing acceptance of new drug application for intravenous antibiotic Carbavance (meropenem-vaborbactam)
21 February 2017 - The Medicines Company today announced that the U.S. FDA has accepted for priority review the Company’s ...
Posted by Michael Wonder on 16 Feb 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar pegfilgrastim for review
16 February 2017 - Second successful BLA filing of the partnership in the U.S. ...
Posted by Michael Wonder on 15 Feb 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for treatment resistant depression
14 February 2017 - Axsome Therapeutics has received fast track designation from the U.S. FDA for AXS-05 for treatment resistant depression. ...
Posted by Michael Wonder on 15 Feb 2017
Amgen submits supplemental biologics license application for Blincyto (blinatumomab) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
14 February 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 08 Feb 2017
FDA grants fast track designation to Angionetics' Generx product candidate, a one-time gene therapy for coronary heart disease
7 February 2017 - Angionetics today reported that the FDA has granted fast track designation for the Phase 3 clinical ...
Posted by Michael Wonder on 08 Feb 2017
Flexion Therapeutics announces new drug application for Zilretta (FX006) accepted by U.S. Food and Drug Administration
7 February 2017 - FDA reviewing Zilretta as potential new treatment for osteoarthritis of the knee. ...
Posted by Michael Wonder on 07 Feb 2017
Perrigo confirms patent challenge for generic version of Onexton Gel
7 February 2017 - Perrigo announced that it has filed an abbreviated new drug application with the U.S. FDA for clindamycin, ...
Posted by Michael Wonder on 06 Feb 2017
Intarcia announces FDA filing acceptance of new drug application for ITCA 650 for the treatment of type 2 diabetes
3 February 2017 - Intarcia Therapeutics announced today that the U.S. FDA has accepted for active review its new drug ...
Posted by Michael Wonder on 04 Feb 2017
Intellipharmaceutics announces FDA acceptance for filing of NDA for Rexista (oxycodone hydrochloride extended release), an abuse deterrent opioid analgesic for the treatment of moderate to severe pain
2 February 2017 - Intellipharmaceutics International today announced that the U.S. FDA has accepted for filing the company's previously-announced new ...
Posted by Michael Wonder on 03 Feb 2017
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings
3 February 2017 - Keytruda also receives breakthrough therapy designation for second-line treatment based on KEYNOTE-045, which includes primary endpoints ...
Posted by Michael Wonder on 02 Feb 2017
Teva confirms generic Victoza patent challenge in the United States
2 February 2017 - Teva Pharmaceuticals today announced that it has filed an abbreviated new drug application with the U.S. ...
Posted by Michael Wonder on 02 Feb 2017
OptiNose announces FDA acceptance for filing of the new drug application for OPN-375
31 January 2017 - FDA sets user fee goal date in September 2017. ...