Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2017
New indication for Briviact (brivaracetam): UCB’s newest anti-epileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
15 September 2017 - Approval applies a newly established regulatory pathway which allows monotherapy treatment options to reach epilepsy patients sooner. ...
Posted by Michael Wonder on 17 Sep 2017
Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older
14 September 2017 - Aptiom provides an important new treatment option for children and adolescents four to 17 years of age ...
Posted by Michael Wonder on 17 Sep 2017
CSL Behring announces FDA approval of Privigen [immune globulin intravenous (human), 10% liquid] for the treatment of chronic inflammatory demyelinating polyneuropathy in adults
14 September 2017 - Privigen shown to improve functional abilities in patients with a rare neurological condition. ...
Posted by Michael Wonder on 14 Sep 2017
FDA permits marketing of mobile medical application for substance use disorder
14 September 2017 - Today, the U.S. FDA permitted marketing of the first mobile medical application to help treat substance use ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves new treatment for adults with relapsed follicular lymphoma
14 September 2017 - The U.S. FDA today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves first biosimilar for the treatment of cancer
14 September 2017 - Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and ...
Posted by Michael Wonder on 13 Sep 2017
Array BioPharma announces FDA acceptance for review of binimetinib and encorafenib new drug applications for patients with advanced BRAF-mutant melanoma
12 September 2017 - Array BioPharma today announced that the U.S. FDA has accepted for review its new drug applications to ...
Posted by Michael Wonder on 10 Sep 2017
Sobi receives approval from the FDA for once-daily dosing frequency of Orfadin for the treatment of HT-1
5 September 2017 - Sobi has received approval from the U.S. FDA for a reduced dosing frequency for Orfadin (nitisinone) ...
Posted by Michael Wonder on 07 Sep 2017
Global Blood Therapeutics receives rare paediatric disease designation from FDA for GBT440 for treatment of sickle cell disease
5 September 2017 - Global Blood Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation to GBT440 ...
Posted by Michael Wonder on 03 Sep 2017
SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
31 August 2017 - Company to meet and work with FDA to address issues raised. ...
Posted by Michael Wonder on 03 Sep 2017
Sanofi receives tentative FDA approval of Admelog (insulin lispro) 100 units/mL
1 September 2017 - Sanofi announced today that the U.S. FDA granted tentative approval for Admelog (insulin lispro injection) 100 ...
Posted by Michael Wonder on 01 Sep 2017
FDA approves Mylotarg for treatment of acute myeloid leukaemia
1 September 2017 - The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with ...
Posted by Michael Wonder on 31 Aug 2017
FDA expands use of Teva’s Austedo in Parkinson’s
31 August 2017 - Teva’s Austedo is now the first and only therapy approved in the US to treat both ...
Posted by Michael Wonder on 31 Aug 2017
FDA approves Genentech’s Actemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome
30 August 2017 - Actemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T ...
Posted by Michael Wonder on 30 Aug 2017
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice
30 August 2017 - Novartis also announces innovative collaboration with the US Centers for Medicare and Medicaid Services. ...