Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Apr 2018
Why Trump’s tariffs could raise the cost of a hip replacement
6 April 2018 - Pacemakers and artificial joints. Defibrillators. Dental fillings. Birth-control pills and vaccines. All are made in China, ...
Posted by Michael Wonder on 07 Apr 2018
FDA rejects Teva/Celltrion biosimilars
6 April 2018 - Teva and Celltrion’s attempt to muscle in on the multi-billion dollar US cancer and inflammatory disease ...
Posted by Michael Wonder on 07 Apr 2018
Drug makers have to post policies for patients seeking experimental medicines. Not all do.
5 April 2018 - Drug companies are routinely flouting a law requiring that they publicly disclose detailed policies on how ...
Posted by Michael Wonder on 07 Apr 2018
Rubraca (rucaparib) approved in the U.S. as maintenance treatment of recurrent ovarian cancer
6 April 2018 - Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a ...
Posted by Michael Wonder on 07 Apr 2018
Pacira announces FDA approval of supplemental new drug application for Exparel as a nerve block to produce regional analgesia
6 April 2018 - Exparel is now an opioid-free option for use as an interscalene brachial plexus block for upper extremity ...
Posted by Michael Wonder on 06 Apr 2018
Antares Pharma provides Xyosted regulatory update
5 April 2018 - Complete response resubmission accepted – PDUFA date 29 September 2018. ...
Posted by Michael Wonder on 06 Apr 2018
Stemline Therapeutics announces start of rolling BLA submission for SL-401
5 April 2018 - Stemline Therapeutics announced today that it has initiated its rolling submission of a biologics license application for ...