Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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 02 Oct 2021
Medical device reforms to lower health fund premiums
2 October 2021 - Health fund premium rises will be 20% lower next year, and the reason for the savings ...
Posted by Michael Wonder on 01 Oct 2021
Japan’s MHLW approves Pfizer’s Cibinqo (abrocitinib) for adults and adolescents with moderate to severe atopic dermatitis
1 October 2021 - Pfizer today announced that the Japanese Ministry of Health, Labour and Welfare has approved Cibinqo (abrocitinib), ...
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
Alternative option for common disease listed on PBS for the first time
1 October 2021 - The federal government will for the first time share the costs of an alternative treatment for two ...
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
NICE terminates another two appraisals
29 September 2021 - Four terminations for the month. ...
Posted by Michael Wonder on 30 Sep 2021
U.S. House panel approves fourth bill aimed at drug prices
30 September 2021 - The U.S. House Judiciary Committee voted Thursday to approve a fourth bill aimed at tackling high ...
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
Schedule of Pharmaceutical Benefits - 1 October 2021
1 October 2021 - The October 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
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
TLV gets a leading role in European HTA project
29 September 2021 - TLV is one of 13 European authorities that are now part of a project called EUnetHTA21. ...