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RSS FeedPosted by Michael Wonder on 30 Sep 2021
DiaMedica Therapeutics announces fast track designation granted to DM199 for the treatment of acute ischaemic stroke
30 September 2021 - DiaMedica Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s lead ...
Posted by Michael Wonder on 30 Sep 2021
FDA grants priority review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer
28 September 2021 - Novartis announced today that the US FDA has accepted and granted Priority Review to the company’s New ...
Posted by Michael Wonder on 30 Sep 2021
FDA clears first major imaging device advancement for computed tomography in nearly a decade
30 September 2021 - The device uses the emerging CT technology of photon counting detectors which can measure each individual X-ray ...
Posted by Michael Wonder on 30 Sep 2021
COVID-19 vaccine weekly safety report (30 September 2021)
30 September 2021 - To 26 September 2021, approximately 26.8 million vaccine doses have been given in Australia – 16.1 million ...
Posted by Michael Wonder on 30 Sep 2021
Medicines industry continues to protect Australians from medicine shortages
30 September 2021 - ACCC extends approval for ongoing collaboration ...
Posted by Michael Wonder on 30 Sep 2021
Acacia Pharma announces submission and validation of marketing authorisation application for Barhemsys (amisulpride injection) in major European markets
29 September 2021 - Acacia Pharma announces that its marketing authorisation application for Barhemsys (amisulpride injection) has been submitted, validated and ...
Posted by Michael Wonder on 30 Sep 2021
Zogenix submits supplemental new drug application for Fintempla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
28 September 2021 - Supplemental new drug application submission is supported by existing clinical data, including positive data from Company’s Phase ...
Posted by Michael Wonder on 29 Sep 2021
Data protection scheme for assessed listed medicines
29 September 2021 - The TGA has implemented a data protection scheme for assessed listed medicines. ...
Posted by Michael Wonder on 29 Sep 2021
Global disparity in access to novel therapeutics for metastatic prostate cancer
29 September 2021 - Access to androgen receptor directed therapies, which also have life-prolonging benefits in the castration-resistant prostate cancer ...
Posted by Michael Wonder on 29 Sep 2021
TransMedics receives FDA approval for its OCS Liver System for preservation and assessment of donor livers for transplantation
29 September 2021 - TransMedics today announced that the U.S. FDA has granted pre-market approval of its OCS Liver System ...
Posted by Michael Wonder on 29 Sep 2021
Benefit-risk assessment for new drug and biological products
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...
Posted by Michael Wonder on 29 Sep 2021
Helsinn Group and BridgeBio Pharma’s affiliate QED Therapeutics announce Health Canada conditional approval of Truseltiq (infigratinib) for patients with cholangiocarcinoma
29 September 2021 - Health Canada issues conditional approval of Truseltiq under Project Orbis (27 September 2021). ...
Posted by Michael Wonder on 29 Sep 2021
NuCana receives fast track designation from the U.S. Food and Drug Administration for Acelarin (NUC-1031) for the treatment of biliary tract cancer
29 September 2021 - NuCana announced that the U.S. FDA has granted fast track designation to Acelarin (NUC-1031), currently being evaluated ...
Posted by Michael Wonder on 29 Sep 2021
U.S. FDA approves Livmarli (maralixibat) as the first and only approved medication for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older
29 September 2021 - Mirum Pharmaceuticals today announced that the U.S. FDA has approved Livmarli (maralixibat) oral solution for the treatment ...
Posted by Michael Wonder on 29 Sep 2021
U.S. FDA accepts filings for Amicus’ AT-GAA for the treatment of Pompe disease
29 September 2021 - FDA sets PDUFA target action date of 29 May 2022 for the new drug application and 29 ...