Blog
RSS FeedPosted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free ...
Posted by Michael Wonder on 01 Mar 2022
Lexicon voluntarily withdraws sotagliflozin new drug application and plans prompt resubmission targeted early Q2 2022
28 February 2022 - Resubmission to Correct Recently-Identified Technical Issue. ...
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 28 Feb 2022
AbbVie seeks new indication for Imbruvica (ibrutinib) in paediatric patients with chronic graft versus host disease
28 February 2022 - The sNDA and NDA submissions were primarily based on results of three years of data from ...
Posted by Michael Wonder on 28 Feb 2022
Amryt receives complete response letter from the FDA for Oleogel-S10 NDA
28 February 2022 - Amryt receives complete response letter from the FDA for Oleogel-S10 NDA. ...
Posted by Michael Wonder on 28 Feb 2022
GC Pharma receives complete response letter from the U.S. FDA for Alyglo
27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 28 Feb 2022
Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation
21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...
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 26 Feb 2022
Reata Pharmaceuticals receives complete response letter from the FDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
25 February 2022 - Reata Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 26 Feb 2022
FDA accepts for review Pfizer’s supplemental application for Abrilada (adalimumab-afzb) interchangeability
25 February 2022 - Pfizer today announced that the U.S. FDA has accepted for review the prior approval supplement to the ...
Posted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 25 Feb 2022
Updating the Bayh-Dole Act; march-in rights and transparency
24 February 2022 - The Patent and Trademark Law Amendments Act (Bayh-Dole Act [35 USC §200-212]) was enacted in 1980 and ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 24 Feb 2022
Viz.ai receives FDA 510(k) clearance for Viz Aneurysm
24 February 2022 - Viz.ai today announced it has received U.S. FDA 510(k) clearance for Viz Aneurysm. ...
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. ...