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.
ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe plaque psoriasis. This groundbreaking approval represents a paradigm shift in dermatology, offering patients unprecedented efficacy with complete skin clearance in over 70% of clinical trial participants.
osentyx FDA approval marks first IL-17A inhibitor for pediatric patients 12+ with hidradenitis suppurativa. Discover how this breakthrough treatment transforms care for adolescents facing HS.
On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy
