Brussels (Belgium) 03 November 2025, 22:00: (CET) – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that KYGEVVI® has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d), with an age of symptom...
treatment News
TARRYTOWN, N.Y. and PARIS – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined...
Toronto, Ontario and Chicago, Illinois — Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus’s supplemental Biologics License Application (sBLA) for IXINITY® [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of...
RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary...
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha...
Rahway, NJ – Merck’s HIF-2α inhibitor Welireg (belzutifan) has netted another FDA approval, this time in treating advanced renal cell carcinoma following treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor. On Friday, the New Jersey-based pharma announced that the approval is based...
RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the north America, today announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group...
THOUSAND OAKS, Calif. – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or...
New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI) and now before chemotherapy Pluvicto significantly reduced risk of progression or death by 59% and more than doubled median radiographic progression-free survival (rPFS) vs. change in ARPI in Phase III PSMAfore trial* Approximately half...
Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets...