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 23 Nov 2022
Rezvoglar becomes second interchangeable insulin biosimilar
23 November 2022 - The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it ...
Posted by Michael Wonder on 23 Nov 2022
ICER to assess gene therapies for sickle cell disease
23 November 2022 - Report will be subject of CTAF meeting in June 2023; draft scoping document open to public ...
Posted by Michael Wonder on 23 Nov 2022
InnoCare announces approval of Hibruka (orelabrutinib) for the treatment of mantle cell lymphoma in Singapore
22 November 2022 - InnoCare Pharma announced today that Hibruka (orelabrutinib) has been approved by the Health Sciences Authority of Singapore ...
Posted by Michael Wonder on 23 Nov 2022
Axicabtagene ciloleucel for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after one systemic treatment
23 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...
Posted by Michael Wonder on 23 Nov 2022
BioMarin announces advancements in FDA review of Roctavian (valoctocogene roxaparvovec) for adults with severe haemophilia A
23 November 2022 - FDA no longer plans to hold an advisory committee meeting, as previously planned, to discuss the biologics ...
Posted by Michael Wonder on 23 Nov 2022
CSL lands world first gene therapy with $5.3 million haemophilia treatment
23 November 2022 - Australian biotech giant CSL will bring the first gene therapy for haemophilia B to market in ...
Posted by Michael Wonder on 23 Nov 2022
MSAC Secretariat publishes agenda for March 2023 MSAC meeting
23 November 2022 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC ...
Posted by Michael Wonder on 23 Nov 2022
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of moderate to severe active Crohn's disease
23 November 2022 - Third approved indication for Skyrizi (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's ...
Posted by Michael Wonder on 23 Nov 2022
Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA
23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...
Posted by Michael Wonder on 23 Nov 2022
Palisade Bio is granted fast track designation from the US FDA for LB1148 for accelerated return of bowel function following GI surgery
22 November 2022 - Palisade Bio today announced that the US FDA has granted fast track designation to LB1148 for ...
Posted by Michael Wonder on 23 Nov 2022
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
22 November 2022 - Blueprint Medicines today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 23 Nov 2022
Agenda for the March 2023 PBAC meeting
23 November 2022 - The agenda for the March 2023 PBAC meeting is now available. ...
Posted by Michael Wonder on 23 Nov 2022
Pacylex granted FDA fast track designation for PCLX-001 for the treatment of relapsed or refractory acute myeloid leukaemia
22 November 2022 - Pacylex today announced that the US FDA has granted PCLX-001 fast track designation for the treatment of ...
Posted by Michael Wonder on 23 Nov 2022
FDA approves first gene therapy to treat adults with haemophilia B
22 November 2022 - Today, the US FDA approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment ...