The New England Journal of Medicine has retracted the pivotal 2021 clinical trial paper for Amgen’s rare-disease drug Tavneos (avacopan). The retraction follows an FDA investigation revealing undisclosed modifications to patient outcome data after the database was locked and unblinded.
AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Pfizer Inc. announced the landmark FDA expansion of IBRANCE (palbociclib) in combination with anti-HER2 and endocrine therapies for HR+, HER2+ metastatic breast cancer frontline maintenance following successful Phase 3 PATINA trial results.
Gilead Sciences announced that the European Commission has approved Trodelvy as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors, based on the landmark Phase 3 ASCENT-03 study.
The historic Utebzi FDA approval introduces the first and only oral carbapenem antibiotic for adult patients suffering from complicated urinary tract infections (cUTIs), offering an effective outpatient treatment pathway to combat multidrug-resistant pathogens.
US Food and Drug Administration has approved AstraZeneca’s Truqap (capivasertib) combination therapy as the first and only targeted treatment for adult patients suffering from PTEN-deficient mAPMN/S prostate cancer.
Roche announces FDA Priority Review for giredestrant, the first oral SERD showing positive phase III results in the curative, adjuvant setting for ER-positive early breast cancer.
The FDA has approved a label expansion for Johnson & Johnson’s TREMFYA® (guselkumab), cementing its position as the first IL-23 inhibitor with data showing it stops the progression of structural joint damage.
AbbVie’s DECNUPAZ FDA approval provides a critical therapeutic lifeline for adult patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This ultra-rare and highly aggressive [Read More…]
AstraZeneca has announced a three-month extension to the FDA’s review period for camizestrant, a promising treatment for HR+/HER2- advanced breast cancer with ESR1 mutations.
