Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2022
Importing oncology trials from China: a bridge over troubled waters?
4 February 2022 - On 10 February 2022, the US FDA's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a ...
Posted by Michael Wonder on 05 Feb 2022
Confirming the next FDA commissioner is a matter of national preparedness
5 February 2022 - The COVD-19 pandemic has shown in bold relief our lack of national preparedness in the realm of ...
Posted by Michael Wonder on 04 Feb 2022
Lawmakers grill key FDA official over controversial Alzheimer’s drug approval
3 February 2022 - The FDA can’t escape questions about Aduhelm. ...
Posted by Michael Wonder on 02 Feb 2022
Global consequences of the US FDA's accelerated approval of cancer drugs
1 February 2022 - The accelerated approval system is a fast track drug approval pathway created by the US FDA in ...
Posted by Michael Wonder on 01 Feb 2022
CDER explores series of draft guidances on real world data, real world evidence - drug information update
31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by ...
Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
Posted by Michael Wonder on 14 Jan 2022
Senate panel advances Biden's FDA pick in 13-8 vote
13 January 2022 - Two senators on the panel who caucus with Democrats and six Republicans opposed the nomination. ...
Posted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...