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RSS FeedPosted by Michael Wonder on 05 Dec 2018
FDA grants priority review to Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
4 December 2018 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants fast track designation for AMG 420
3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...
Posted by Michael Wonder on 04 Dec 2018
The Biosimilars Forum joins calls for FDA action on biosimilar communications
3 December 2018 - The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA ...
Posted by Michael Wonder on 04 Dec 2018
Shield Therapeutics announces the new drug application for Feraccru has been accepted for filing and review by the FDA
3 December 2018 - Shield Therapeutics today announces that the US FDA has accepted for review the new drug application ...
Posted 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4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...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 ...