Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose
19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to ...
Posted by Michael Wonder on 20 Apr 2019
Health Canada approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis
18 April 2019 - Approval of Skyrizi (risankizumab) is based on results from clinical studies showing significant improvement in levels of ...
Posted by Michael Wonder on 17 Apr 2019
Ultragenyx announces UX007 granted fast track designation and rare pediatric disease designation by U.S. FDA for treatment of long-chain fatty acid oxidation disorders
16 April 2019 - Company on track to submit NDA to FDA in mid 2019. ...
Posted by Michael Wonder on 17 Apr 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of beta thalassemia
16 April 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated today announced that the U.S. FDA has granted fast track ...
Posted by Michael Wonder on 17 Apr 2019
Increasing access to new treatments for special patient populations
16 April 2019 - Health Canada is helping Canadians get timely access to new drugs. ...
Posted by Michael Wonder on 16 Apr 2019
Aprea Therapeutics receives FDA fast track designation and orphan drug designation for APR-246 for the treatment of myelodysplastic syndromes
16 April 2019 - Aprea Therapeutics today announced that the U.S. FDA has granted fast track designation to APR-246 for ...
Posted by Michael Wonder on 16 Apr 2019
Labor to fast-track leukaemia drug trials
17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...
Posted by Michael Wonder on 16 Apr 2019
Recordati to seek Canadian approval for kidney disease drug
17 April 2019 - Italy’s Recordati said on Tuesday it plans to seek Canadian approval for its drug Cystagon, which ...
Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 16 Apr 2019
FDA to launch new website next week
16 April 2019 - In his first “all hands” speech at the US FDA White Oak campus on Tuesday, Acting ...
Posted by Michael Wonder on 16 Apr 2019
Evenity (romosozumab-aqqg) now available in the United States for the treatment of osteoporosis in post-menopausal women at high risk for fracture
15 April 2019 - New therapy to cost one-third less than other bone-building agents over full course of therapy. ...
Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...
Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...
Posted by Michael Wonder on 14 Apr 2019
Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
12 April 2019 - EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of ...
Posted by Michael Wonder on 14 Apr 2019
Biopharma CEOs explain problems with biosimilars to Congress
12 April 2019 - Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds ...