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
Innovative Cellular Therapeutics receives FDA fast track designation for GCC19CART, its lead solid tumour candidate, in the treatment of patients with relapsed or refractory metastatic colorectal cancer
19 April 2022 - GCC19CART is an autologous CAR T therapy candidate that has shown promising results in over 30 relapsed ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 19 Apr 2022
Supply related data in manufacturer dossiers: things are not going smoothly yet
19 April 2022 - The criteria for supply related data established by IQWiG in 2020 were positively received in science. ...
Posted by Michael Wonder on 19 Apr 2022
Aytu BioPharma announces fast track designation granted to AR101 for the treatment of vascular Ehlers-Danlos syndrome
19 April 2022 - Aytu BioPharma today announced that the U.S. FDA has granted fast track designation to AR101 (enzastaurin), a ...
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 ...