Blog
RSS FeedPosted by Michael Wonder on 10 Jan 2024
AARP statement on FDA’s prescription drugs importation approval for Florida
8 January 2024 - AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond issued the following statement ...
Posted by Michael Wonder on 08 Jan 2024
Florida is first state allowed to import drugs from Canada in bid to reduce costs
5 January 2024 - FDA’s decision could change the way Americans obtain prescription medicines. ...
Posted by Michael Wonder on 29 Aug 2023
Janssen submits supplemental new drug application to the US FDA seeking full approval of Balversa (erdafitinib) for the treatment of patients with locally advanced or metastatic urothelial carcinoma and selected fibroblast growth factor receptor gene alterations
28 August 2023 - Submission based on confirmatory data from cohort 1 of the Phase 3 THOR study, which showed ...
Posted by Michael Wonder on 20 Jun 2023
FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers
20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...
Posted by Michael Wonder on 08 Jun 2023
SAR443579/IPH6101 receives FDA fast track designation in the US for the treatment of haematological malignancies
8 June 2023 - SAR443579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research ...
Posted by Michael Wonder on 31 Aug 2022
Governor Ron DeSantis announces lawsuit against Biden Administration’s reckless delay of Canadian Prescription Drug Importation Program
31 August 2022 - Today, Governor Ron DeSantis announced a lawsuit against the US FDA in response to their unreasonable delay ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...
Posted by Michael Wonder on 08 Oct 2021
Health Canada approves the use of Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis
7 October 2021 - Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...
Posted by Michael Wonder on 30 Aug 2020
FDA grants priority review of melflufen for patients with triple-class refractory multiple myeloma
29 August 2020 - Oncopeptides today announces that the US FDA has granted priority review for Oncopeptides' new drug application ...
Posted by Michael Wonder on 15 Jul 2020
FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines. ...
Posted by Michael Wonder on 17 Jun 2020
Regulators discuss accelerated approvals, Project Orbis at DIA
16 June 2020 - Regulators from the US FDA, European Medicines Agency and Health Canada gave their perspectives on different ...
Posted by Michael Wonder on 06 May 2020
Importing prescription drugs from Canada — legal and practical problems with the Trump Administration’s proposal
7 May 2020 - The Trump administration has proposed a rule that, if finalised, would allow states to develop programs to ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...