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RSS FeedPosted by Michael Wonder on 14 Mar 2022
Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo
14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 12 Mar 2022
Acadia Pharmaceuticals announces 4 August 2022 action date for resubmitted supplemental new drug application for Nuplazid (pimavanserin) for the treatment of Alzheimer’s disease psychosis
9 March 2022 - The FDA plans to hold an advisory committee meeting. ...
Posted by Michael Wonder on 03 Mar 2022
Medicines Australia welcomes reform efforts to speed up clinical trials
4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...
Posted by Michael Wonder on 03 Mar 2022
TG Therapeutics announces extension of U.S. FDA BLA/sNDA PDUFA date for ublituximab plus Ukoniq to treat patients with CLL and SLL
3 March 2022 - FDA sets updated PDUFA goal date of June 25, 2022. ...
Posted by Michael Wonder on 01 Mar 2022
AbbVie provides update regarding Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in the U.S.
28 February 2022 - AbbVie today announced that the U.S. FDA has extended its review period for Skyrizi (risankizumab-rzaa) for ...
Posted by Michael Wonder on 27 Feb 2022
Update on Tyvaso DPI new drug application
24 February 2022 - MannKind Corporation was informed that the U.S. FDA issued an information request to United Therapeutics Corporation ...
Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022. ...
Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022. ...
Posted by Michael Wonder on 22 Feb 2022
The truth about patient access and FDA fast tracking
21 February 2022 - University of Illinois Chicago researchers studied 135 products that received U.S. FDA approval through orphan drug and ...
Posted by Michael Wonder on 10 Feb 2022
National Medicines Policy too important to be rushed before Federal Election
10 February 2022 - Following consultation with members – and heeding the concerns of the Consumers Health Forum and patient ...
Posted by Michael Wonder on 07 Feb 2022
Review of the National Medicines Policy – consultation on draft National Medicines Policy extended
8 February 2022 - The consultation period on the draft NMP was due to close on Wednesday 16 February 2022. ...
Posted by Michael Wonder on 07 Feb 2022
Medicines Australia calls for new National Medicines Policy to be pushed back until after the federal election
4 February 2022 - Medicines Australia is today calling for the new National Medicines Policy to be pushed back until ...
Posted by Michael Wonder on 02 Feb 2022
UK’s Early Access to Medicines Scheme now to be put on a legal footing
2 February 2022 - Significant clarification of the life-changing Early Access to Medicines Scheme to be introduced into law. ...
Posted by Michael Wonder on 30 Jan 2022
Medicines regulator pilot probes pharma delays in market launches
25 January 2022 - The European Medicines Agency wants to get a better understanding of drug companies’ commercial intentions and why. ...
Posted by Michael Wonder on 28 Jan 2022
Australians deserve fast access to the latest medicines, vaccines and treatments
28 January 2022 - Medicines Australia recommends the Australian Government delivers a plan to shorten the time that patients wait ...