Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 04 Apr 2018
Paratek’s new drug applications for oral and intravenous omadacycline accepted for priority review by FDA
4 April 2018 - PDUFA action date in October 2018. ...
Posted by Michael Wonder on 04 Apr 2018
Proteostasis Therapeutics receives FDA fast track designation for triple combination program in patients with cystic fibrosis
4 April 2018 - Proteostasis Therapeutics today announced that the U.S. FDA has granted fast track designation for the company's triple ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 04 Apr 2018
US FDA approves Bydureon for use with basal insulin in patients with type 2 diabetes with inadequate glycemic control
3 April 2018 - Duration-7 study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy vs insulin ...
Posted by Michael Wonder on 04 Apr 2018
Motif Bio initiates NDA rolling submission for iclaprim
3 April 2018 - Motif Bio today announced the initiation of a rolling submission of a new drug application to ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy. ...
Posted by Michael Wonder on 03 Apr 2018
US FDA accepts biologics license application for moxetumomab pasudotox in hairy cell leukaemia
3 April 2018 - Moxetumomab pasudotox application granted priority review. ...