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 13 Apr 2022
BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy
13 April 2022 BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with ...
Posted by Michael Wonder on 13 Apr 2022
ICER releases draft evidence report on gene therapy for beta thalassaemia
13 April 2022 - Public comment period now open until 10 May 2022; requests to make oral comment during public ...
Posted by Michael Wonder on 13 Apr 2022
Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
13 April 2022 - NICE has published evidence based recommendations on the use of daratumumab (Darzalex) for the treatment of ...
Posted by Michael Wonder on 13 Apr 2022
Highest risk COVID-19 patients receive ‘brilliant’ new antivirals at home
9 April 2022 - Thousands of patients with COVID-19 who are most likely to be admitted to hospital are receiving ...
Posted by Michael Wonder on 13 Apr 2022
TGA approves Lumakras
13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...
Posted by Michael Wonder on 12 Apr 2022
US FDA grants fast track designation for Paradigm’s Phase 3 osteoarthritis program
12 April 2022 - Paradigm Biopharmaceuticals is pleased to announce that the U.S. FDA has granted fast track designation for ...
Posted by Michael Wonder on 12 Apr 2022
Health Canada has approved Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis
12 April 2022 - Zeposia is the first and only S1P receptor modulating agent approved for the treatment of ulcerative ...
Posted by Michael Wonder on 12 Apr 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction
12 April 2022 - Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in ...
Posted by Michael Wonder on 12 Apr 2022
EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
Posted by Michael Wonder on 12 Apr 2022
Prospective measures to combat rising drug prices in Germany
13 April 2022 - This article provides an overview of potential tools being explored in Germany by Health Insurance Funds to ...
Posted by Michael Wonder on 12 Apr 2022
NICE reaches important milestone in the UK’s efforts to tackle antimicrobial resistance
12 April 2022 - Two new antimicrobial drugs - cefiderocol and ceftazidime–avibactam - are close to becoming the first to be ...
Posted by Michael Wonder on 12 Apr 2022
Myovant Sciences and Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
12 April 2022 - Myovant Sciences and Pfizer announced today an update on the Supplemental new drug application for Myfembree ...
Posted by Michael Wonder on 12 Apr 2022
Aeglea BioTherapeutics submits BLA to FDA for pegzilarginase for the treatment of arginase 1 deficiency
12 April 2022 - European marketing application on track for submission this year. ...
Posted by Michael Wonder on 12 Apr 2022
FDA grants Direct Biologics regenerative medicine advanced therapy designation for the use of ExoFlo in COVID-19 related ARDS
12 April 2022 - Direct Biologics announced that the U.S. FDA has awarded their EV drug product ExoFlo with a regenerative ...
Posted by Michael Wonder on 12 Apr 2022
TGA approves new medicine for patients with SLE
12 April 2022 - Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type ...