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...
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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...
STOCKHOLM – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration, FDA, has approved PEPAXTO® (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult...
HERSHEY, Pa. — In 2003, the first year of her fellowship in pediatric oncology, two of Giselle Saulnier Sholler’s first three patients had died from neuroblastoma, closely matching the 30% survival rate expected at the time for high-risk neuroblastoma. She knew research was the only way to change these outcomes....
PARIS – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the...
OSAKA, Japan and CAMBRIDGE, Massachusetts – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient,...
Washington DC – The FDA has granted approval to frontline toripalimab-tpzi (Loqtorzi) plus cisplatin and gemcitabine for adult patients with metastatic or locally advanced nasopharyngeal carcinoma (NPC), as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy, according to a press...
WASHINGTON DC – Following in the footsteps of its U.K. counterpart, the FDA on Friday approved the first-ever CRISPR-based gene editing therapy in the form of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) for sickle cell disease, while also granting approval to bluebird bio’s lovo-cel, which will carry the...