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 29 Jun 2024
NICE recommends CSL Behring’s haemophilia B gene therapy Hemgenix
28 June 2024 - NICE has recommended CSL Behring’s haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) for immediate reimbursement by ...
Posted by Michael Wonder on 29 Jun 2024
Rocket Pharmaceuticals provides regulatory update on Kresladi (marnetegragene autotemcel)
28 June 2024 - Rocket Pharmaceuticals today announced a regulatory update for Kresladi (marnetegragene autotemcel), a lentiviral vector-based gene therapy ...
Posted by Michael Wonder on 29 Jun 2024
Soleno Therapeutics announces submission of new drug application to the US FDA for diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for ...
Posted by Michael Wonder on 29 Jun 2024
Mirum submits new drug application to FDA for chenodiol for the treatment of CTX
28 June 2024 - Mirum Pharmaceuticals today announced the submission of a new drug application for chenodiol for the treatment of ...
Posted by Michael Wonder on 29 Jun 2024
Iovance Biotherapeutics submits marketing authorisation application to European Medicines Agency for lifileucel in advanced melanoma
28 June 2024 - First of multiple planned global submissions for lifileucel in 2024 and 2025. ...
Posted by Michael Wonder on 28 Jun 2024
Odronextamab recommended for EU approval by the CHMP to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
28 June 2024 - Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and ...
Posted by Michael Wonder on 28 Jun 2024
2024-25 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
28 June 2024 - 2024-25 PBS) and NIP cost recovery fees commence on 1 July 2024. ...
Posted by Michael Wonder on 28 Jun 2024
Pfizer and BioNTech receive positive CHMP opinion for omicron JN.1 adapted COVID-19 Vaccine in the European Union
27 June 2024 - The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for ...
Posted by Michael Wonder on 28 Jun 2024
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory follicular lymphoma
28 June 2024 - Positive CHMP opinion based on results from the Phase 1/2 EPCORE NHL-1 study. ...
Posted by Michael Wonder on 28 Jun 2024
House panel passes bills to expand Medicare obesity drug coverage, cancer screening
27 June 2024 - A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity ...
Posted by Michael Wonder on 28 Jun 2024
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
26 June 2024 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab), a bispecific CD20 directed CD3 T-cell ...
Posted by Michael Wonder on 27 Jun 2024
Expanding our scientific advice services for the life sciences sector in Canada
26 June 2024 - Canada’s Drug Agency is launching a new one year learning period in our Scientific Advice program ...
Posted by Michael Wonder on 27 Jun 2024
Verona Pharma announces US FDA approval of Ohtuvayre (ensifentrine)
26 June 2024 - First inhaled chronic obstructive pulmonary disease treatment providing bronchodilation and non-steroidal anti-inflammatory effects. ...
Posted by Michael Wonder on 27 Jun 2024
ICER publishes final evidence report on treatment for post-traumatic stress disorder
27 June 2024 - Independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits ...
Posted by Michael Wonder on 27 Jun 2024
Vir Biotechnology receives FDA fast track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection
26 June 2024 - Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for ...