Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2018
FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients
4 December 2018 - Today, the U.S. FDA published the De Novo Classification Proposed Rule, which if finalized, would establish procedures ...
Posted by Michael Wonder on 04 Dec 2018
FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply
4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...
Posted by Michael Wonder on 04 Dec 2018
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
4 December 2018 - The U.S. FDA today took a significant step forward in driving the efficient development of novel diagnostic ...
Posted by Michael Wonder on 04 Dec 2018
Ocular Therapeutix announces FDA approval of Dextenza for the treatment of ocular pain following ophthalmic surgery
3 December 2018 - Dextenza (dexamethasone ophthalmic insert) is the first intra-canalicular insert for drug delivery. ...
Posted by Michael Wonder on 03 Dec 2018
Novartis announces FDA filing acceptance and priority review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
3 December 2018 - The AVXS-101, now known as Zolgensma (onasemnogene abeparvovec-xxxx), filing is supported by data from the START trial ...
Posted by Michael Wonder on 03 Dec 2018
FDA faulted for lapses in orphan drug program
30 November 2018 - The FDA has failed to ensure that drugs given prized rare-disease status meet the intent of ...
Posted by Michael Wonder on 01 Dec 2018
AbbVie announces Humira (adalimumab) global patent license with Pfizer
30 November 2018 - AbbVie announced today patent license agreements with Pfizer over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 01 Dec 2018
‘A loss for the rest of us’: An FDA approval is a boon for a drug maker, but could come at a major cost for patients
30 November 2018 - Vickie Moored can walk again. Her words don’t slur, her vision isn’t blurred, and she no ...
Posted by Michael Wonder on 01 Dec 2018
FDA accepts filing of new oestrogen-free oral contraceptive developed by Exeltis
29 November 2018 - This new method of contraception could offer an improved bleeding profile and greater flexibility for female population. ...
Posted by Michael Wonder on 30 Nov 2018
FDA announces pilot program with WHO to expedite review of HIV drug applications
30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...
Posted by Michael Wonder on 29 Nov 2018
Acceleron receives FDA fast track designation for ACE-083 in Charcot-Marie-Tooth disease
28 November 2018 - Acceleron Pharma today announced that the United States FDA has granted fast track designation to ACE-083, the ...
Posted by Michael Wonder on 29 Nov 2018
Galapagos receives fast track designation from FDA for GLPG1972/S201086 in osteoarthritis
27 November 2018 - Galapagos announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
28 November 2018 - The U.S. FDA today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in adults. ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukaemia with a certain genetic mutation
28 November 2018 - The U.S. FDA today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed ...
Posted by Michael Wonder on 28 Nov 2018
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of ...