Blog
RSS FeedPosted by Michael Wonder on 05 Dec 2015
Best practices for communication between IND sponsors and FDA during drug development
4 December 2015 - The purpose of the draft guidance is to describe best practices and procedures for timely, transparent, ...
Posted by Michael Wonder on 30 Nov 2015
FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma
30 November 2015 - Today the U.S. FDA granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat ...
Posted by Michael Wonder on 25 Nov 2015
FDA approves Portrazza to treat advanced squamous non-small cell lung cancer
24 November 2015 - The U.S. FDA today approved Portrazza (necitumumab) for use in combination with two forms of chemotherapy to ...
Posted by Michael Wonder on 25 Nov 2015
FDA approves vaccine for use after known or suspected anthrax exposure
24 November 2015 - The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with ...
Posted by Michael Wonder on 23 Nov 2015
FDA approves Opdivo to treat advanced form of kidney cancer
23 November 2015 - The U.S. FDA today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a ...
Posted by Michael Wonder on 20 Nov 2015
FDA approves Ninlaro, new oral medication to treat multiple myeloma
20 November 2015 - Today the U.S. FDA granted approval for Ninlaro (ixazomib) for use in combination with two other therapies ...
Posted by Michael Wonder on 19 Nov 2015
FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
18 November 2015 - Today the U.S. FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, ...
Posted by Michael Wonder on 16 Nov 2015
FDA approves Darzalex for patients with previously treated multiple myeloma
16 November 2015 - Today the U.S. FDA granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who ...
Posted by Michael Wonder on 14 Nov 2015
FDA approves new pill to treat certain patients with non-small cell lung cancer
13 November 2015 - Today, the U.S. FDA granted accelerated approval for Tagrisso (osimertinib) for patients whose tumors have a specific ...
Posted by Michael Wonder on 12 Nov 2015
FDA approves Cotellic as part of combination treatment for advanced melanoma
10 November 2015 - The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib ...
Posted by Michael Wonder on 05 Nov 2015
FDA approves new treatment for HIV
5 November 2015 - The U.S. FDA today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) ...
Posted by Michael Wonder on 05 Nov 2015
FDA approves Nucala to treat severe asthma
4 November 2015 - The U.S. FDA has approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment ...
Posted by Michael Wonder on 02 Nov 2015
Merck receives breakthrough therapy designation from U.S. Food and Drug Administration for Keytruda (pembrolizumab) in advanced colorectal cancer
2 November 2015 - This is the third breakthrough therapy designation granted for Keytruda. ...
Posted by Michael Wonder on 29 Oct 2015
FDA approves Yervoy to reduce the risk of melanoma returning after surgery
28 October 2015 - Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a ...
Posted by Michael Wonder on 27 Oct 2015
FDA approves first-of-its-kind product for the treatment of melanoma
27 October 2015 - The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, ...