Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2017
GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus
21 July 2017 - GSK announced today that the US FDA has approved a new subcutaneous formulation of Benlysta (belimumab) for ...
Posted by Michael Wonder on 20 Jul 2017
FDA may publicly shame drug makers for thwarting generic rivals
19 July 2017 - Attention brand-name drug makers: the FDA may soon publicly shame you for thwarting generic rivals. ...
Posted by Michael Wonder on 20 Jul 2017
FDA clears first neonatal magnetic resonance imaging device
20 July 2017 - Today, the U.S. FDA cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain ...
Posted by Michael Wonder on 20 Jul 2017
Merck announces U.S. FDA grants tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin
20 July 2017 - Merck today announced that the U.S. FDA has granted tentative approval for Lusduna Nexvue™ (insulin glargine ...
Posted by Michael Wonder on 18 Jul 2017
FDA approves Vosevi for hepatitis C
18 July 2017 - The U.S. FDA today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 ...
Posted by Michael Wonder on 17 Jul 2017
FDA approves new treatment to reduce the risk of breast cancer returning
17 July 2017 - The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, ...
Posted by Michael Wonder on 14 Jul 2017
Janssen announces U.S. FDA approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis
13 July 2017 - Tremfya is the first and only biologic approved that selectively blocks interleukin 23. ...
Posted by Michael Wonder on 12 Jul 2017
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat paediatric, young adult r/r B-cell ALL
13 July 2017 - Positive ODAC recommendation is latest milestone for CTL019 program that started through collaboration with the University ...
Posted by Michael Wonder on 12 Jul 2017
Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA
11 July 2017 - No efficacy or safety issues raised by FDA. ...
Posted by Michael Wonder on 12 Jul 2017
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in adults and children
11 July 2017 - Data from the phase 3 TOWER study support conversion from accelerated to full approval. ...
Posted by Michael Wonder on 08 Jul 2017
Endo gives in to FDA demand and agrees to yank its opioid painkiller
7 July 2017 - In the end, the executive team at Endo International blinked. ...
Posted by Michael Wonder on 08 Jul 2017
FDA approves new treatment for sickle cell disease
7 July 2017 - The U.S. FDA today approved Endari (L-glutamine oral powder) for patients age five years and older ...
Posted by Michael Wonder on 06 Jul 2017
Bristol-Myers Squibb’s Orencia (abatacept) receives FDA approval for treatment of active psoriatic arthritis in adults
6 July 2017 - Orencia demonstrated symptom improvement in two randomised, double-blind, placebo-controlled trials that included adult patients with psoriatic arthritis ...
Posted by Michael Wonder on 03 Jul 2017
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
3 July 2017 - Today, the U.S. FDA cleared the expanded use of a cooling cap, DigniCap Cooling System, to ...
Posted by Michael Wonder on 30 Jun 2017
FDA approves Vectibix (panitumumab) for use in wild type RAS metastatic colorectal cancer
29 June 2017 - Approved companion diagnostic tool strengthens precision medicine approach. ...