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 26 May 2022
Janssen’s psoriatic arthritis drug Tremfya gets insurance coverage
26 May 2022 - Janssen Korea said that the Ministry of Health and Welfare would begin to reimburse Tremfya, its ...
Posted by Michael Wonder on 26 May 2022
Kiwi women plead for PHARMAC funding of a newly approved breakthrough treatment for ovarian cancer
27 May 2022 - Kiwi women living with advanced ovarian cancer can now access a breakthrough new treatment. ...
Posted by Michael Wonder on 26 May 2022
NICE recommends Libtayo (cemiplimab) for routine NHS commissioning as the first and only systemic treatment for advanced CSCC in England
25 May 2022 - NICE has published a positive Final Appraisal Determination recommending Libtayo (cemiplimab) as the first and only ...
Posted by Michael Wonder on 26 May 2022
Reata Pharmaceuticals announces FDA filing acceptance and priority review designation for the NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
26 May 2022 - Application assigned a PDUFA date of 30 November 2022. ...
Posted by Michael Wonder on 26 May 2022
Pfizer granted FDA fast track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis
26 May 2022 - Pfizer today announced the U.S. FDA has granted fast track designation to Pfizer’s investigational combination therapy ...
Posted by Michael Wonder on 26 May 2022
European Commission approves Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early stage triple negative breast cancer at high risk of recurrence
24 May 2022 - Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial. ...
Posted by Michael Wonder on 26 May 2022
COVID-19 vaccine weekly safety report (26 May 2022)
26 May 2022 - To 22 May 2022, the TGA has received 555 reports which have been assessed as likely to ...
Posted by Michael Wonder on 26 May 2022
Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
25 May 2022 - Approval is based on pivotal data from the Phase 3 POLARIX study, where Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 26 May 2022
Prescription medicines: applications under evaluation (May 2022)
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 26 May 2022
Romosozumab for treating severe osteoporosis
25 May 2022 - NICE has published evidence-based recommendations on the use of romosozumab for patients with severe osteoporosis. ...
Posted by Michael Wonder on 26 May 2022
TGA approves new medicine for patients with Cushing's syndrome
26 May 2022 - Osilodrostat phosphate is a cortisol synthesis inhibitor. ...
Posted by Michael Wonder on 25 May 2022
Phathom Pharmaceuticals announces FDA acceptance for filing of vonoprazan NDA for the treatment of erosive oesophagitis
25 May 2022 - Phathom Pharmaceuticals announced today the U.S. FDA has accepted for review the company’s new drug application for ...
Posted by Michael Wonder on 25 May 2022
Medicare spending on drugs with accelerated approval
24 May 2022 - The U.S. FDA provides accelerated approval to drugs on the basis of surrogate end points deemed to ...
Posted by Michael Wonder on 25 May 2022
Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges
25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials. ...
Posted by Michael Wonder on 25 May 2022
Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates
24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...