Blog
RSS FeedPosted by Michael Wonder on 16 Apr 2018
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) combination as first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma
16 April 2018 - The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall ...
Posted by Michael Wonder on 15 Apr 2018
Cutting-edge cancer drug hobbled by diagnostic test confusion
9 April 2018 - Physicians struggle to identify which patients are likely to respond to a recently approved therapy. ...
Posted by Michael Wonder on 15 Apr 2018
Ironed out
12 April 2018 - During the early part of the 20th century, the growing scientific knowledge that certain diseases were caused ...
Posted by Michael Wonder on 13 Apr 2018
Rhizen Pharmaceuticals receives FDA fast track designation for tenalisib (RP6530), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed and/or refractory cutaneous T-cell lymphoma
13 April 2018 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for tenalisib, the Company’s ...
Posted by Michael Wonder on 13 Apr 2018
Fresenius Kabi announces new approval and immediate availability of daptomycin for injection
12 April 2018 - Fresenius Kabi announced today it has received FDA approval for daptomycin for injection and the product ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 12 Apr 2018
Demand cancer drugs that truly help patients
10 April 2018 - Already this year, the US FDA has approved or extended the use of several cancer drugs ...
Posted by Michael Wonder on 11 Apr 2018
Breakthrough-therapy designation — an FDA perspective
12 April 2018 - Recent medical advances, such as targeted therapies for specific tumour genomic defects, checkpoint inhibitors for cancers, and ...
Posted by Michael Wonder on 11 Apr 2018
The FDA breakthrough-drug designation — four years of experience
12 April 2018 - In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of ...
Posted by Michael Wonder on 11 Apr 2018
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
11 April 2018 - The U.S. FDA today permitted marketing of the first medical device to use artificial intelligence to detect ...
Posted by Michael Wonder on 11 Apr 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with penta-refractory multiple myeloma
10 April 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s lead, ...
Posted by Michael Wonder on 11 Apr 2018
Novartis’ Afinitor Disperz wins new TSC-related approval
11 April 2018 - Novartis’ Afinitor Disperz has become the first medicine to be specifically approved by US regulators to ...
Posted by Michael Wonder on 10 Apr 2018
FDA clears first contact lens with light-adaptive technology
10 April 2018 - The U.S. FDA today cleared the first contact lens to incorporate an additive that automatically darkens the ...
Posted by Michael Wonder on 10 Apr 2018
AbbVie and Neurocrine Biosciences announce PDUFA target date of Q3 2018 for elagolix in endometriosis-associated pain
10 April 2018 - FDA requires extended time for review of additional information in new drug application. ...
Posted by Michael Wonder on 09 Apr 2018
FDA accepts new drug application for duvelisib and grants priority review
9 April 2018 - Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic ...