Blog
RSS FeedPosted by Michael Wonder on 28 Oct 2017
FDA grants breakthrough therapy designation for BioMarin's valoctocogene roxaparvovec (formerly BMN 270), an investigational gene therapy for hemophilia A
26 October 2017 - Global phase 3 program to begin before year end. ...
Posted by Michael Wonder on 28 Oct 2017
AbbVie receives U.S. FDA priority review for investigational oral treatment elagolix for the management of endometriosis with associated pain
27 October 2017 - If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain ...
Posted by Michael Wonder on 27 Oct 2017
Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis
25 October 2017 - Fast track designation follows recent FDA approval of pivotal Phase 2/3 clinical trial in IPF. ...
Posted by Michael Wonder on 27 Oct 2017
FDA accepts Genentech’s supplemental biologics license application for Avastin as a front-line treatment for women with advanced ovarian cancer
25 October 2017 - Genentech announced today that the U.S. FDA has accepted the company's supplemental biologics license application for ...
Posted by Michael Wonder on 27 Oct 2017
MorphoSys receives FDA breakthrough therapy designation for its antibody MOR208 in relapsed/refractory DLBCL
23 October 2017 - Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in ...
Posted by Michael Wonder on 26 Oct 2017
New shingles vaccine endorsed over competitor by expert panel, a boost for GSK
25 October 2017 - The expert panel that helps guide U.S. vaccination policy has voted to give a preferential recommendation ...
Posted by Michael Wonder on 26 Oct 2017
PTC Therapeutics receives complete response letter for ataluren's NDA
25 October 2017 - PTC Therapeutics today announced that the Office of Drug Evaluation I of the U.S. FDA has ...
Posted by Michael Wonder on 26 Oct 2017
Tesaro announces U.S. FDA approval of Varubi IV for delayed nausea and vomiting associated with cancer chemotherapy
25 October 2017 - Availability of new formulation offers healthcare providers the flexibility to choose oral or IV administration. ...
Posted by Michael Wonder on 25 Oct 2017
Medivir receives FDA fast track designation for MIV-711 for the treatment of osteoarthritis
24 October 2017 - Medivir today announced that the U.S. FDA has granted fast track designation for the company´s product ...
Posted by Michael Wonder on 24 Oct 2017
FDA grants fast track designation to Alzheon’s ALZ-801 development program for the treatment of Alzheimer’s disease
24 October 2017 - Company’s phase 3 clinical program pioneers a precision medicine approach in Alzheimer’s disease. ...
Posted by Michael Wonder on 24 Oct 2017
Medical device development tools: helping to speed medical device evaluation and approval
24 October 2017 - The FDA relies on sound science in its decision-making, which provides medical device innovators with a ...
Posted by Michael Wonder on 24 Oct 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
24 October 2017 - Enabling patients and providers to have efficient access to new and innovative medical products that meet ...
Posted by Michael Wonder on 24 Oct 2017
FDA approves Soliris (eculizumab) for the treatment of patients with generalised myasthenia gravis
23 October 2017 - First FDA approved treatment in more than 60 years for patients with generalised myasthenia gravis, a ...
Posted by Michael Wonder on 24 Oct 2017
US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type 2 diabetes
23 October 2017 - New formulation of once-weekly exenatide in an improved device provides significant HbA1c reduction with added benefit ...
Posted by Michael Wonder on 24 Oct 2017
United Therapeutics announces FDA approval of third generation nebuliser for the Tyvaso inhalation system
23 October 2017 - United Therapeutics today announced approval by the U.S. FDA of a new inhalation device, called the ...