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 05 Oct 2021
Heron Therapeutics announces filing of a supplemental new drug application for significant expansion of Zynrelef indication statement based on successful outcome of FDA type C meeting
4 October 2021 - FDA agreed to the immediate filing of supplemental new drug application to significantly expand the Zynrelef indication ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 05 Oct 2021
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with NTRK positive, TKI pretreated advanced solid tumours
4 October 2021 - Turning Point Therapeutics today announced the U.S. FDA granted a seventh regulatory designation to lead drug ...
Posted by Michael Wonder on 05 Oct 2021
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...
Posted 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
The U.S. can lower drug prices without sacrificing innovation
1 October 2021 - Legislation giving Medicare the ability to negotiate drug prices in the United States would make their ...
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 ...