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RSS FeedPosted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
Posted by Michael Wonder on 03 Apr 2023
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
3 April 2023 - Today, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) ...
Posted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
Posted by Michael Wonder on 23 Mar 2023
FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or ...
Posted by Michael Wonder on 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 18 Feb 2023
Travere Therapeutics announces FDA accelerated approval of Filspari (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy
17 February 2023 - Interim results from the ongoing Phase 3 PROTECT head to head trial demonstrated a rapid, sustained and ...
Posted by Michael Wonder on 15 Feb 2023
FDA gene therapy head raises concern on accelerated approval use
14 February 2023 - More than 1,000 cell and gene therapy clinical trials registered. ...
Posted by Michael Wonder on 03 Feb 2023
Medicare may test policy of paying less for accelerated approval drugs
31 January 2023 - Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that ...
Posted by Michael Wonder on 31 Jan 2023
Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway
27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 27 Jan 2023
FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma
27 January 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for relapsed or refractory mantle ...
Posted by Michael Wonder on 25 Jan 2023
The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals
25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...
Posted by Michael Wonder on 19 Jan 2023
Seagen announces FDA accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for people with previously treated RAS wild type, HER2 positive metastatic colorectal cancer
19 January 2023 - First FDA approved treatment in HER2 positive metastatic colorectal cancer. ...
Posted by Michael Wonder on 06 Jan 2023
FDA grants accelerated approval for Alzheimer’s disease treatment
6 January 2023 - Today, the US FDA approved Leqembi (lecanemab-irmb) via the accelerated approval pathway for the treatment of Alzheimer’s ...
Posted by Michael Wonder on 23 Dec 2022
FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma
22 December 2022 - Today, the FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech), a bispecific CD20 directed CD3 T-cell ...