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RSS FeedPosted by Michael Wonder on 01 Nov 2016
Novartis LEE011 (ribociclib) granted FDA priority review for first-line treatment of HR+/HER2- advanced breast cancer
1 November 2016 - A marketing authorization application for LEE011 plus letrozole has also been accepted for review by the ...
Posted by Michael Wonder on 21 Oct 2016
U.S. FDA accepts for priority review the supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer
21 October 2016 - Submission based on results from Phase 2 study CheckMate-275 evaluating Opdivo in patients with previously treated platinum-refractory ...
Posted by Michael Wonder on 11 Oct 2016
FDA grants priority review to Roche's Lucentis for mCNV
11 October 2016 - The U.S. FDA has granted priority review for Roche drug Lucentis (ranibizumab) for treating myopic choroidal ...
Posted by Michael Wonder on 26 Sep 2016
Sanofi and Regeneron announce dupilumab biologics license application accepted for priority review by U.S. FDA
26 September 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the biologics ...
Posted by Michael Wonder on 14 Sep 2016
FDA’s expedited programs and their impact on the availability of new therapies
7 September 2016 - The US FDA’s priority review, accelerated approval, fast track, and breakthrough therapy programs have been successful in ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...
Posted by Michael Wonder on 02 Aug 2016
FDA accepts BLA for BioMarin's cerliponase alfa for CLN2 disease, form of Batten disease
27 July 2016 - Potential first treatment for fatal, rare, brain disease in children. ...
Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis. ...
Posted by Michael Wonder on 18 May 2016
FDA approves new, targeted treatment for bladder cancer
18 May 2016 - Tecentriq is the first PD-L1 inhibitor approved by the FDA. ...
Posted by Michael Wonder on 05 May 2016
FDA grants priority review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
4 May 2016 - Eli Lilly announced today that the U.S. FDA has granted priority review for the biologics license application ...
Posted by Michael Wonder on 04 May 2016
FDA grants priority review for Amgen's supplemental biologics license application for Blincyto (blinatumomab)
3 May 2016 - Amgen today announced that the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 01 May 2016
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
29 April 2016 - The U.S. FDA today approved Nuplazid (pimavanserin tartrate), the first drug approved to treat hallucinations and delusions ...
Posted by Michael Wonder on 14 Apr 2016
U.S. FDA accepts for priority review Bristol-Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) for the treatment of classical Hodgkin's lymphoma patients
14 April 2016 - Bristol-Myers Squibb Company announced today that the U.S. FDA accepted a supplemental biologics license application which seeks ...