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RSS FeedPosted by Michael Wonder on 05 Oct 2021
Pharmaceutical industry backs workplace vaccinations
5 October 2021 - Medicines Australia strongly recommends full COVID-19 vaccinations for the health and safety and protection of all ...
Posted by Michael Wonder on 04 Oct 2021
ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir for children living with HIV
4 October 2021 - ViiV Healthcare has announced it has made a regulatory submission to the U.S. FDA for approval of ...
Posted by Michael Wonder on 04 Oct 2021
Enhertu granted breakthrough therapy designation in U.S.for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
4 October 2021 - Based on groundbreaking DESTINY-Breast03 results where Enhertu reduced the risk of disease progression or death by 72% ...
Posted by Michael Wonder on 02 Oct 2021
Omeros provides regulatory update on biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy
1 October 2021 - Omeros Corporation today announced that the U.S. FDA notified the company that, as part of FDA’s on-going ...
Posted by Michael Wonder on 02 Oct 2021
FDA, sponsors advance reliance on real world data & evidence
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...
Posted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for LAG-3 blocking antibody relatlimab and nivolumab fixed dose combination as first-line treatment for patients with unresectable or metastatic melanoma
1 October 2021 - The Phase 2/3 RELATIVITY-047 trial served as the basis for this application, in which a statistically ...
Posted by Michael Wonder on 02 Oct 2021
TGA advice on recognition of COVID-19 vaccines not registered in Australia but used internationally
1 October 2021 - The TGA has undertaken an assessment on the protection offered by certain COVID-19 vaccines that are ...
Posted 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 ...