Biocon Receives U.S. FDA Approval for Yesintek® Ustekinumab Autoinjector
Biocon has announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Yesintek® (ustekinumab-kfce) as a single-dose prefilled autoinjector. Yesintek® is a biosimilar to Stelara® (ustekinumab), a biologic therapy used across several immune-mediated inflammatory diseases. The approval represents another advancement in Biocon’s expanding biosimilar portfolio and strengthens its presence in the U.S. immunology market.
Finerenone and Nephrolithiasis Risk: Insights from Real-World Evidence
Finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), has demonstrated renoprotective benefits in people with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM). However, its potential association with nephrolithiasis has not been well characterized. A newly published real-world study in Scientific Reports evaluated the incidence of kidney stones among patients receiving finerenone compared with other commonly used CKD therapies.
USFDA Grants Zydus Final Approval and 180-Day CGT Exclusivity for Indocyanine Green for Injection
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has granted final approval for Indocyanine Green for Injection, USP, 25 mg/vial, with eligibility for 180-day Competitive Generic Therapy (CGT) exclusivity. The approval represents an important milestone for the company, reflecting its continued focus on expanding its portfolio of complex injectable generic medicines while addressing areas with limited generic competition. Under the CGT pathway, the first approved applicant receives a period of market exclusivity following commercial launch, encouraging the development of generic medicines for products with inadequate competition.
Prof GIUSEPPE MANCIA
Prof. Enrico Agabiti Rosei at ESH 2019 Milan part 1
Prof. Enrico Agabiti Rosei at ESH 2019 Milan part 2
Professor Dame Anna Dominiczak at ESH 2019 Milan
