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.
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.
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…]
Datroway FDA approval for TNBC was officially granted today, marking a transformative shift in the management of one of the most aggressive forms of breast [Read More…]
Accord BioPharma and Bio-Thera Solutions achieve a historic FDA approval for ImmGolis, the first interchangeable simponi biosimilar to reach the U.S. market.
AstraZeneca and Daiichi Sankyo’s Enhertu achieves milestone FDA approvals in two early-stage HER2-positive breast cancer settings, reshaping curative care.
The recent STELARA FDA approval provides a crucial new non-TNF biologic treatment option for children two years and older suffering from moderately to severely active Crohn’s disease.
Eli Lilly has officially received Foundayo FDA approval for orforglipron, the first daily non-peptide oral GLP-1 receptor agonist that offers significant weight loss results without the dietary restrictions of previous oral treatments.
