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 08 Sep 2022
Revance announces FDA approval of Daxxify (daxibotulinumtoxinA-lanm) for injection, the first and only peptide formulated neuromodulator with long-lasting results
8 September 2022 - Based on the data from SAKURA, Daxxify has the ability to deliver year long results with as ...
Posted by Michael Wonder on 08 Sep 2022
ViewRay announces China NMPA approval of its MRIdian MRI guided radiation therapy for cancer patients
7 September 2022 - This approval expands MRIdian's global reach and offers cancer patients a new radiation therapy option—MRIdian SMART. ...
Posted by Michael Wonder on 08 Sep 2022
COVID-19 vaccine safety report (8 August 2022)
8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...
Posted by Michael Wonder on 08 Sep 2022
Silence Therapeutics announces FDA fast track designation for SLN124, a novel investigational siRNA therapy for the treatment of polycythemia vera
8 September 2022 - Designation provides potential for expedited drug development path. ...
Posted by Michael Wonder on 08 Sep 2022
Grifols enters into agreement with Canadian Blood Services to accelerate self-sufficiency in immunoglobulins for Canada
7 September 2022 - The country, with an increasing immunoglobulin usage rate, currently imports about 85% of its immunoglobulin demand for ...
Posted by Michael Wonder on 08 Sep 2022
Health Canada approves Pluvicto as first targeted radioligand therapy for progressive PSMA positive metastatic castration-resistant prostate cancer
7 September 2022 - Novel mechanism of action of Pluvicto binds to target PSMA positive cancer cells, delivering radiation treatment directly ...
Posted by Michael Wonder on 08 Sep 2022
Pharmac issues RFP for intravenous trastuzumab, a medicine used to treat breast cancer
8 September 2022 - PHARMAC is seeking commercial bids from pharmaceutical suppliers for the supply of intravenous trastuzumab, a ‘biologic’ ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 07 Sep 2022
Ongoing uncertainty about prices will deter new drug launches in Canada
7 September 2022 - Further delays in access or complete denials of access to innovative drugs will hurt even more Canadians ...
Posted by Michael Wonder on 07 Sep 2022
Doctors call for vaccine u-turn from PHARMAC after surge in preventable pneumococcal cases
8 September 2022 - When drug-buying agency PHARMAC switched to a cheaper vaccine covering fewer strains of potentially deadly pneumococcal ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
Posted by Michael Wonder on 07 Sep 2022
AmMax Bio announces AMB-05X granted FDA fast track designation for the treatment of tenosynovial giant cell tumour
7 September 2022 - Proof of concept established in Phase 2 Trial of TGCT, with positive efficacy results across multiple clinical ...
Posted by Michael Wonder on 07 Sep 2022
CDER and CBER accept first submission to ISTAND pilot program
7 September 2022 - The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have ...
Posted by Michael Wonder on 07 Sep 2022
The FDA needs to be more flexible in assessing treatments for rare diseases, like the one that seemed to help my son
7 September 2022 - Every time I read about clinical trials testing possible treatments for rare diseases, I think of ...
Posted by Michael Wonder on 07 Sep 2022
Seres Therapeutics announces completion of rolling BLA submission to FDA for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection
7 September 2022 - Investigational therapeutic SER-109 has the potential to become the first-ever FDA approved oral microbiome therapeutic. ...