Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2018
AB Science announces that the CHMP has adopted a negative opinion for the marketing authorization of masitinib in amyotrophic lateral sclerosis
19 April 2018 - AB Science will provide additional data through a re-examination procedure. ...
Posted by Michael Wonder on 21 Apr 2018
Sunovion announces Health Canada approval of Latuda (lurasidone hydrochloride) to treat adolescents (13 to 17 years of age) wth bipolar depression
20 April 2018 - Sunovion today announced that Health Canada has approved the supplemental new drug submission that expands the ...
Posted by Michael Wonder on 19 Apr 2018
Xultophy approved in Canada for the treatment of adults with type 2 diabetes
18 April 2018 - Once-daily Xultophy has been shown to help patients achieve blood glucose targets. ...
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 18 Apr 2018
Sobi receives approval from Health Canada for once-daily dosing of Orfadin (nitisinone) for the treatment of HT-1
17 April 2018 - First and only nitisinone product in Canada approved for once-daily use, designed to meet the needs of ...
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 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new ...
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
Penthrox receives marketing authorisation from Health Canada for adult patients requiring relief from moderate to severe acute pain associated with trauma or interventional medical procedures
10 April 2018 - Purdue Pharma (Canada) and Medical Developments International Limited, announce today that Penthrox, a low dose methoxyflurane, has ...