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RSS FeedPosted by Michael Wonder on 24 May 2017
U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated hepatocellular carcinoma
24 May 2017 - Application is based on results from the Phase 1/2 CheckMate-040 trial. ...
Posted by Michael Wonder on 24 May 2017
Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...
Posted by Michael Wonder on 23 May 2017
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma
23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting. ...
Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response ...
Posted by Michael Wonder on 04 Apr 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated dMMR or MSI-H metastatic colorectal cancer
4 April 2017 - Application based on results from Phase 2 CheckMate-142 study. ...
Posted by Michael Wonder on 04 Apr 2017
AbbVie announces Ibrutinib (Imbruvica) supplemental new drug application for previously treated chronic graft-versus-host-disease accepted for review by U.S. FDA
4 April 2017 - AbbVie today announced a supplemental new drug application was accepted for review by the U.S. FDA for ...
Posted by Michael Wonder on 30 Mar 2017
FDA grants priority review for Amgen's Blincyto (blinatumomab) supplemental biologics license application
29 March 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 30 Mar 2017
FDA officials: priority review drugs have higher likelihood of getting boxed warning after approval
29 March 2017 - A team of officials from the US FDA say that drugs approved following a priority review ...
Posted by Michael Wonder on 29 Mar 2017
Novartis announces first CAR-T cell therapy BLA for paediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review
29 March 2017 - Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using ...
Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 ...
Posted by Michael Wonder on 28 Mar 2017
FDA grants priority review for Eagle Pharmaceuticals’ Ryanodex NDA for the treatment of exertional heat stroke
27 March 2017 - Eagle Pharmaceuticals announced today that their 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment ...
Posted by Michael Wonder on 25 Mar 2017
Symbiomix Therapeutics announces FDA’s acceptance of new drug application for Solosec with priority review status
23 March 2017 - Symbiomix today announced that the US FDA has accepted for filing the Company’s new drug application for ...
Posted by Michael Wonder on 23 Mar 2017
This is not a test: RMAT designation goes live
21 March 2017 - The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue ...
Posted by Michael Wonder on 21 Mar 2017
Humacyte receives FDA regenerative medicine advanced therapy expedited review designation for Humacyl in vascular access for haemodialysis
20 March 2017 - Humacyte announced today that the U.S. FDA has granted Humacyl, its investigational human acellular vessel, the ...
Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase ...