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RSS FeedPosted 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
Remarks from FDA Commissioner Scott Gottlieb on fiscal year 2019 budget request for FDA
17 April 2018 - As prepared for delivery to U.S. House Subcommittee on Agriculture, Rural Development. ...
Posted by Michael Wonder on 17 Apr 2018
FDA medical device safety action plan now available
17 April 2018 - FDA's vision to protect patients and promote public health. ...
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
Alkermes announces FDA acceptance for review of new drug application for ALKS 5461 for the adjunctive treatment of major depressive disorder
16 April 2018 - FDA action expected by 31 January 2019. ...
Posted by Michael Wonder on 16 Apr 2018
Eagle Pharmaceuticals’ vasopressin ANDA accepted for filing by the FDA
16 April 2018 - Eagle Pharmaceuticals today announced that it has submitted and the U.S. FDA has accepted for filing ...
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 15 Apr 2018
Cutting-edge cancer drug hobbled by diagnostic test confusion
9 April 2018 - Physicians struggle to identify which patients are likely to respond to a recently approved therapy. ...
Posted by Michael Wonder on 15 Apr 2018
Ironed out
12 April 2018 - During the early part of the 20th century, the growing scientific knowledge that certain diseases were caused ...
Posted by Michael Wonder on 13 Apr 2018
Rhizen Pharmaceuticals receives FDA fast track designation for tenalisib (RP6530), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed and/or refractory cutaneous T-cell lymphoma
13 April 2018 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for tenalisib, the Company’s ...
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 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 12 Apr 2018
Demand cancer drugs that truly help patients
10 April 2018 - Already this year, the US FDA has approved or extended the use of several cancer drugs ...