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 19 Apr 2022
Novavax announces approval of Nuvaxovid COVID-19 vaccine for primary and booster immunisation in Japan
19 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adults aged 18 and older in ...
Posted by Michael Wonder on 19 Apr 2022
Lenvatinib and pembrolizumab in endometrial cancer: patients live significantly longer
19 April 2022 - There is an indication of a considerable added benefit compared to doxorubicin or paclitaxel. Compared to ...
Posted by Michael Wonder on 19 Apr 2022
Adicet Bio receives FDA fast track designation for lead candidate ADI-001
19 April 2022 - Adicet Bio today announced the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Apr 2022
US Food and Drug Administration accepts new drug application for daprodustat
19 April 2022 - Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase 3 ...
Posted by Michael Wonder on 19 Apr 2022
EMA publishes agenda for 19-22 April 2022 CHMP meeting
19 April 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Apr 2022
Enhertu granted priority review in the U.S. for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer
19 April 2022 - Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a 54.9% tumour response ...
Posted by Michael Wonder on 19 Apr 2022
Prescription medicines: applications under evaluation (April 2022)
19 April 2022 - The TGA has updated its list of applications for new medicines or new uses for existing medicines ...
Posted by Michael Wonder on 19 Apr 2022
Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...
Posted by Michael Wonder on 18 Apr 2022
Risks to the 340B drug pricing program related to manufacturer restrictions on drug availability
15 April 2022 - On 21 March 2022, Johnson & Johnson became the 16th pharmaceutical manufacturer to restrict the delivery of ...
Posted by Michael Wonder on 18 Apr 2022
Switzerland approves its first protein-based Covid vaccine
15 April 2022 - Swissmedic announced its approval on Wednesday making Nuvaxovid the first protein-based vaccine to be licensed in Switzerland. ...
Posted by Michael Wonder on 18 Apr 2022
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...
Posted by Michael Wonder on 18 Apr 2022
Securing the future of Australia’s world class healthcare system
17 April 2022 - Under the changes announced today, an additional 71,000 Australians will have access to continuous glucose monitoring and ...
Posted by Michael Wonder on 18 Apr 2022
China NMPA approves tislelizumab for patients with second-line oesophageal squamous cell carcinoma
15 April 2022 - Tislelizumab is now approved for eight indications in China. ...
Posted by Michael Wonder on 16 Apr 2022
When will SMA oral drug Evrysdi get insurance benefits?
14 April 2022 - Roche’s new spinal muscular atrophy oral treatment Evrysdi (risdiplam) proved the benefit of convenience and cost ...
Posted by Michael Wonder on 15 Apr 2022
Valneva COVID-19 vaccine approved by MHRA
14 April 2022 - The COVID-19 vaccine developed by Valneva has today been given regulatory approval by the MHRA. ...