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RSS FeedPosted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...
Posted by Michael Wonder on 01 Oct 2025
Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease
1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...
Posted by Michael Wonder on 01 Oct 2025
White House unveils ‘TrumpRx’ drug buying site and a Pfizer pricing deal
30 September 2025 - The company says it gains a three year grace period to exempt it from national-security-related tariffs. ...
Posted by Michael Wonder on 01 Oct 2025
Disc Medicine announces submission of new drug application to US FDA for accelerated approval of bitopertin for patients with erythropoietic protoporphyria
30 September 2025 - Disc is seeking accelerated approval and priority review of its new drug application submission. ...
Posted by Michael Wonder on 01 Oct 2025
Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once weekly basal insulin treatment for adults with type 2 diabetes
29 September 2025 - Awiqli (insulin icodec) injection, if approved, has the potential to be the first once weekly basal insulin ...
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
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
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. ...