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 27 May 2022
FDA grants breakthrough device designation for Emily's Care Nourish Test System
26 May 2022 - Lactation Lab has announced today that the U.S. FDA, has granted the company breakthrough device designation ...
Posted by Michael Wonder on 26 May 2022
From scientific discovery to covered treatments: understanding the payer perspective as a keystone to achieving high value care
26 May 2022 - The mission of the National Institutes of Health is to translate scientific discovery into health by designing ...
Posted by Michael Wonder on 26 May 2022
Perrigo announces U.S. FDA approval for omeprazole magnesium delayed release mini capsules
26 May 2022 - Perrigo today announced that it has received final approval from the U.S. FDA for omeprazole magnesium delayed ...
Posted by Michael Wonder on 26 May 2022
Revolutionary wearable ultrasound device gains FDA approval
26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...
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. ...