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RSS FeedPosted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for mavacamten for the treatment of obstructive hypertrophic cardiomyopathy
1 October 2021 - Application based on positive results from Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 02 Oct 2021
Formycon and Bioeq announce file acceptance for FYB201, a biosimilar candidate to Lucentis (ranibizumab) by the U.S. FDA
1 October 2021 - Formycon and its license partner Bioeq announce that the U.S. FDA accepted the biologics license application for ...
Posted by Michael Wonder on 02 Oct 2021
FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 October 2021 - Today, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 01 Oct 2021
Kite submits supplemental biologics license application to U.S. FDA for earlier use of Yescarta in large B-cell lymphoma
30 September 2021 - Supplemental biologics license application filing based on landmark ZUMA-7 study, the first randomised clinical trial to evaluate ...
Posted by Michael Wonder on 01 Oct 2021
PharmaMar announces the approval of Zepzelca (lurbinectedin) for the treatment of relapsed stage III or metastatic small cell lung cancer in Canada
30 September 2021 - Lurbinectedin to become commercially available in Canada in the coming months. ...
Posted by Michael Wonder on 01 Oct 2021
TG Therapeutics submits biologics license application to the U.S. FDA for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
30 September 2021 - TG Therapeutics today announced the submission of a biologics license application to the U.S. FDA requesting approval ...
Posted by Michael Wonder on 01 Oct 2021
Xbrane Biopharma announces that partner Stada's marketing authorisation application for ranibizumab is submitted and validated by European Medicines Agency
30 September 2021 - Xbrane Biopharma today announces that a marketing authorisation Application for biosimilar ranibizumab submitted by its co-development ...
Posted 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. ...