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 Oct 2025
EMA publishes agenda for 13-16 October 2025 CHMP meeting
13 October 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Oct 2025
US FDA approves updated indication statement for Rinvoq (upadacitinib) for the treatment of inflammatory bowel disease
13 October 2025 - Updated indication allows the use of Rinvoq (upadacitinib) prior to the use of tumour necrosis factor blocking ...
Posted by Michael Wonder on 11 Oct 2025
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
10 October 2025 - Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them ...
Posted by Michael Wonder on 11 Oct 2025
SQ Innovation announces FDA approval of Lasix ONYU for treatment of edema in heart failure
8 October 2025 - -- SQ Innovation today announced that the US FDA has approved its drug-device combination Lasix ONYU ...
Posted by Michael Wonder on 11 Oct 2025
FDA frants RMAT designation to Avobis Bio's implantable cell therapy AVB-114 for Crohn's perianal fistulas
3 October 2025 - Avobis Bio announced today that the US FDA has granted regenerative medicine advanced therapy designation for AVB-114, ...
Posted by Michael Wonder on 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable ...
Posted by Michael Wonder on 10 Oct 2025
AstraZeneca announces historic agreement with US Government to lower the cost of medicines for American patients
10 October 2025 - AstraZeneca today announces a historic agreement with President Donald J. Trump’s administration to lower the cost ...
Posted by Michael Wonder on 10 Oct 2025
Cidara Therapeutics receives US FDA breakthrough therapy designation for CD388 in seasonal influenza prevention
9 October 2025 - Cidara Therapeutics today announced that the US FDA has granted breakthrough therapy designation for CD388 for prevention ...
Posted by Michael Wonder on 10 Oct 2025
Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma
9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...
Posted by Michael Wonder on 10 Oct 2025
DUSC utilisation analysis public release documents (April 2025)
10 October 2025 - The utilisation analysis public release documents from the April 2025 DUSC meeting are now available. ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...
Posted by Michael Wonder on 10 Oct 2025
US FDA approves Boehringer’s Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade
9 October 2025 - Approval is based on results from two clinical trials, which showed reduction in forced vital capacity decline ...
Posted by Michael Wonder on 09 Oct 2025
Why the Government must urgently raise the NICE cost effectiveness threshold
7 October 2025 - NICE plays an important role in determining whether new medicines will be funded for NHS patients ...
Posted by Michael Wonder on 09 Oct 2025
Ascendis submits marketing authorisation application to the EMA for TransCon CNP for treatment of children with achondroplasia
8 October 2025 - Ascendis Pharma today announced it has submitted a marketing authorisation application to the EMA for TransCon CNP ...
Posted by Michael Wonder on 09 Oct 2025
Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva
29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...