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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 30 Sep 2025
Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies
30 September 2025 - Umoja Biopharma announced today that the US FDA has granted fast track designation to UB-VV111 for the ...
Posted by Michael Wonder on 30 Sep 2025
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from methamphetamine
30 September 2025 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 30 Sep 2025
AbbVie submits biologics license application to US FDA for pivekimab sunirine - an investigational antibody-drug conjugate to treat rare cancer with limited treatment options
30 September 2025 - Biologics license application based on data from the global Phase 1/2 CADENZA trial. ...
Posted by Michael Wonder on 30 Sep 2025
Schedule of Pharmaceutical Benefits - 1 October 2025
1 October 2025 - The October 2025 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 30 Sep 2025
Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria
30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology ...
Posted by Michael Wonder on 30 Sep 2025
Pfizer reaches landmark agreement with US Government to lower drug costs for American patients
30 September 2025 - Voluntary agreement meets the President’s four requests while also protecting the US ecosystem responsible for America’s leadership ...
Posted by Michael Wonder on 30 Sep 2025
Novo Nordisk submits biologics license application to FDA for Mim8; an investigational, prophylaxis treatment for people living with haemophilia A with or without inhibitors
29 September 2025 - In haemophilia A, denecimig is designed to help the body form blood clots more effectively and was ...
Posted by Michael Wonder on 30 Sep 2025
FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer
29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer ...
Posted by Michael Wonder on 30 Sep 2025
Kedrion Biopharma receives FDA approval for Qivigy (immune globulin 10% IV) for treatment of primary humoral immunodeficiency in Adults
29 September 2025 - Kedrion Biopharma announced today that it has received FDA approval for Qivigy immune globulin intravenous (human)-kthm 10% ...
Posted by Michael Wonder on 30 Sep 2025
US FDA approves Tremfya (guselkumab) for the treatment of paediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
29 September 2025 - Approval was based on PROTOSTAR study, which showed paediatric patients receiving Tremfya achieved high levels of ...
Posted by Michael Wonder on 29 Sep 2025
ICER to assess vaccines for COVID-19
29 September 2025 - Report will be subject of New England CEPAC meeting in June 2026. ...
Posted by Michael Wonder on 29 Sep 2025
AbbVie announces UK pricing strategy for Elahere (mirvetuximab soravtansine-gynx)
29 September 2025 - The list price will be consistent with the US to reflect the value of the innovation. ...
Posted by Michael Wonder on 29 Sep 2025
New life changing medicines listed on the PBS
28 September 2025 - From 1 October 2025, Australians affected by breast cancer and rare kidney disease will have access ...
Posted by Michael Wonder on 29 Sep 2025
EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner
22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 28 Sep 2025
Donald Trump is waging war on sky-high drug prices. Can he win?
28 September 2025 - Big Pharma has a big headache: Donald Trump. Lately drugmakers have had to contend with the ...