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 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
Posted by Michael Wonder on 21 Jul 2022
ATAGI update following weekly COVID-19 meeting (20 July 2022)
21 July 2022 - The ATAGI met on 20 July 2022 to consider the latest developments relating to COVID-19 immunisation. ...
Posted by Michael Wonder on 21 Jul 2022
TGA approves Padcev
21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...
Posted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...
Posted by Michael Wonder on 20 Jul 2022
For Medicaid insured patients with cancer, health insurance does not always mean health access
15 July 2022 - Although there has been a significant increase in the number of U.S. residents insured through Medicaid since ...
Posted by Michael Wonder on 20 Jul 2022
The big squeeze?
20 July 2022 - With NHS England highlighting savings of £1.2 billion on medicines in three years coming from both ...
Posted by Michael Wonder on 20 Jul 2022
FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides' Pepaxto
20 July 2022 - Oncopeptides today announces that the US FDA, has announced a forthcoming public advisory meeting of the ...
Posted by Michael Wonder on 20 Jul 2022
FDA approves Qsymia for the treatment of obesity in adolescents ages 12-17
20 July 2022 - Vivus today announced that the U.S. FDA approved Qsymia (phentermine and topiramate extended-release capsules) for use in ...
Posted by Michael Wonder on 20 Jul 2022
Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes
20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for ...
Posted by Michael Wonder on 20 Jul 2022
Easier access to locally applied HRT to treat post-menopausal vaginal symptoms in landmark MHRA reclassification
20 July 2022 - From September women in the UK will be able to access Gina 10 microgram vaginal tablets without ...
Posted by Michael Wonder on 20 Jul 2022
Statement by President Joe Biden on FDA and CDC authorising Novavax’s COVID-19 vaccine for adults
19 July 2022 - Today is another step forward in our nation’s fight against the virus. Following an independent scientific review ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL
19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Jul 2022
Ascentage Pharma and Innovent announce the China NMPA accepted and granted priority review designation to a new drug application for olverembatinib for the treatment of drug resistant CML
19 July 2022 - Ascentage Pharma and Innovent Biologics today announce that the Center for Drug Evaluation of China's NMPA ...
Posted by Michael Wonder on 19 Jul 2022
ICER publishes final evidence report and policy recommendations on beti-cel gene therapy for beta thalassaemia
19 July 2022 - Independent appraisal committee unanimously determined that evidence is adequate to demonstrate that beti-cel provides a net ...