Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 21 Mar 2022
Provention Bio announces FDA acceptance of the biologics license application resubmission for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
21 March 2022 - FDA Sets Goal Date of August 17, 2022. ...
Posted 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. ...