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 07 Jan 2022
NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of lung cancer
7 January 2022 - With over 48,000 new cases diagnosed per year, lung cancer is the third most common cancer ...
Posted by Michael Wonder on 07 Jan 2022
Dynacure receives fast track designation for DYN101, an investigational antisense oligonucleotide for the treatment of myotubular and centronuclear myopathies
6 January 2022 - Dynacure today announced that the U.S. FDA has granted fast track designation for its lead product ...
Posted by Michael Wonder on 07 Jan 2022
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) approved in Japan for patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
27 December 2021 - First approval in Japan for the Keytruda plus Lenvima combination. ...
Posted by Michael Wonder on 07 Jan 2022
Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17
6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...
Posted by Michael Wonder on 06 Jan 2022
ICER publishes evidence report on tirzepatide for type 2 diabetes
6 January 2022 - Tirzepatide has a novel dual GIP and GLP-1 receptor agonist mechanism of action and is seen as ...
Posted by Michael Wonder on 06 Jan 2022
Updated agenda for the March 2022 PBAC meeting
5 January 2022 - The agenda for the March 2022 PBAC meeting has been updated. ...
Posted by Michael Wonder on 05 Jan 2022
U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer
3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...
Posted by Michael Wonder on 05 Jan 2022
Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...
Posted by Michael Wonder on 05 Jan 2022
FDA grants breakthrough therapy designation for Cullinan Oncology’s CLN-081 in patients with locally advanced or metastatic EGFR mutated non-small-cell lung cancer
4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for ...
Posted by Michael Wonder on 04 Jan 2022
TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)
4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...
Posted by Michael Wonder on 04 Jan 2022
AbbVie announces U.S. FDA granted breakthrough therapy designation to telisotuzumab vedotin for previously treated non-small-cell lung cancer
4 January 2022 - There are currently no approved cancer therapies specifically for patients with c-Met overexpressing non-small-cell lung cancer. ...
Posted by Michael Wonder on 04 Jan 2022
Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...
Posted by Michael Wonder on 04 Jan 2022
Consultation paper on proposal to introduce a cost recovered pathway for Medical Services Advisory Committee applications
4 January 2022 - The Department of Health invites submissions in relation to a proposal to introduce a cost recovered ...
Posted by Michael Wonder on 04 Jan 2022
Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices?
3 January 2022 - Astellas Pharma, a drug company headquartered in Japan, is charging U.S. patients $156,000 a year for ...
Posted by Michael Wonder on 04 Jan 2022
Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022. ...