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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
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 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022. ...
Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 22 Nov 2021
Bristol Myers Squibb announces new PDUFA date for mavacamten
19 November 2021 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the new ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...