Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2024
Confirmatory trials of accelerated approval drugs — will imposing fines reduce delays?
5 October 2024 - In 1992, patient advocacy groups convinced the FDA to develop an accelerated approval program, which allowed new ...
Posted by Michael Wonder on 14 Aug 2024
Gilead’s Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by US FDA
14 August 2024 - First and only treatment to demonstrate statistically significant reductions across key biomarkers, ALP normalisation and pruritus versus ...
Posted by Michael Wonder on 07 Aug 2024
Novartis receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy
8 August 2024 - Fabhalta achieved a 44% proteinuria reduction from baseline in Phase 3 APPLAUSE-IgAN interim analysis, compared with 9% ...
Posted by Michael Wonder on 28 Jun 2024
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
26 June 2024 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab), a bispecific CD20 directed CD3 T-cell ...
Posted by Michael Wonder on 13 Jun 2024
FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...
Posted by Michael Wonder on 11 Jun 2024
Ipsen’s Iqirvo receives US FDA accelerated approval as a first in class PPAR treatment for primary biliary cholangitis
10 June 2024 - Approval based on positive Phase 3 ELATIVE trial data. ...
Posted by Michael Wonder on 16 May 2024
FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer
16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...
Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
Posted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 27 Apr 2024
Use evidence to support early coverage of gene therapy after accelerated approval
23 April 2024 - Gene editing and therapy to replace missing or defective genes is one of the most exciting ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 01 Dec 2023
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
Posted by Michael Wonder on 21 Nov 2023
FDA faces reckoning over short-cut drug approvals
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
Posted by Michael Wonder on 10 Sep 2023
The accelerated approval program for cancer drugs — finding the right balance
9 September 2023 - Implementation of the accelerated approval program has been rocky in recent years. ...
Posted by Michael Wonder on 14 Aug 2023
FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), a bispecific B-cell maturation antigen directed ...