Blog
RSS FeedPosted 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 16 Dec 2021
FDA grants Calliditas Therapeutics accelerated approval of Tarpeyo (budesonide) to reduce proteinuria in IgA nephropathy
15 December 2021 - Tarpeyo (developed under the project name Nefecon) is the first and only FDA approved treatment that was ...
Posted by Michael Wonder on 17 Oct 2021
Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval
8 October 2021 - In this cross-sectional study of 216 drugs granted accelerated approval from 1992 through 2020, relative to all ...
Posted by Michael Wonder on 12 Oct 2021
FDA’s accelerated approval program: is change on the way?
11 October 2021 - The U.S. FDA launched its accelerated approval program in 1992, offering a pathway to bring life saving ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 22 Aug 2021
Accelerated approval - an unexpected pathway to value-based pricing?
18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...
Posted by Michael Wonder on 17 Aug 2021
FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours
17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...
Posted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...
Posted by Michael Wonder on 02 Aug 2021
FDA’s Pazdur challenges attack on accelerated approval program
2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...
Posted by Michael Wonder on 31 Jul 2021
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab ...
Posted by Michael Wonder on 07 Jun 2021
FDA grants accelerated approval for Alzheimer’s drug
7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...
Posted by Michael Wonder on 21 May 2021
FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer
21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...
Posted by Michael Wonder on 05 May 2021
FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer
5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...
Posted by Michael Wonder on 05 May 2021
Curtailing Medicaid coverage of accelerated approval therapies threatens patients' access
3 May 2021 - To improve their COVID-battered fiscal situations, some states are looking to cut Medicaid, which makes up ...