Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer
27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...
Posted by Michael Wonder on 21 Apr 2021
“Dangling” accelerated approvals in oncology
21 April 2021 - The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing ...
Posted by Michael Wonder on 16 Jan 2021
FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...
Posted by Michael Wonder on 25 Nov 2020
FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow
25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...
Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...
Posted by Michael Wonder on 11 Mar 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib
11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting. ...
Posted by Michael Wonder on 25 Nov 2019
FDA approves voxelotor for sickle cell disease
25 November 2019 - The Food and Drug Administration has granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for ...
Posted by Michael Wonder on 14 Nov 2019
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage
14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 07 Jul 2019
Fast-track drug approval, designed for emergencies, is now routine
5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...
Posted by Michael Wonder on 06 Jun 2019
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...
Posted by Michael Wonder on 28 May 2019
Assessment of the clinical benefit of cancer drugs receiving accelerated approval
28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...
Posted by Michael Wonder on 07 Sep 2017
Drug makers push back on data requirements in Australia’s provisional approval pathway
5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...