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RSS FeedPosted by Michael Wonder on 25 Apr 2018
Otsuka’s Jynarque (tolvaptan) approved by U.S. FDA as the first treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
25 April 2018 - Data from two phase 3 clinical trials showed that Jynarque (tolvaptan) slowed kidney function decline in adults ...
Posted by Michael Wonder on 19 Apr 2018
US FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer
18 April 2018 - Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard ...
Posted by Michael Wonder on 18 Apr 2018
FDA provides full approval to Praxbind, specific reversal agent for Pradaxa
17 April 2018 - Decision converts Praxbind’s (idarucizumab) accelerated approval, granted in October 2015, to full approval. ...
Posted by Michael Wonder on 17 Apr 2018
FDA approves Vonvendi [von Willebrand factor (recombinant)] for peri-operative management of bleeding in adult patients with von Willebrand disease
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on ...
Posted by Michael Wonder on 17 Apr 2018
Rigel announces FDA approval of Tavalisse (fostamatinib disodium hexahydrate) for chronic immune thrombocytopenia in adult patients
17 April 2018 - Tavalisse offers first-in-class treatment with unique mechanism of action. ...
Posted by Michael Wonder on 17 Apr 2018
FDA grants breakthrough therapy designation for Roche’s Hemlibra in haemophilia A without inhibitors
17 April 2018 - Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no ...
Posted by Michael Wonder on 17 Apr 2018
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphataemia
17 April 2018 - The U.S. FDA today approved Crysvita (burosumab), the first drug approved to treat adults and children ages ...
Posted 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 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 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
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 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 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 ...