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....
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NEW YORK, NY – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or...
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The FDA evaluated Libtayo under Priority Review, which is...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines...
Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US Diabetic retinopathy affects almost 10 million people in the US...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has...
Paris, France – The US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz met the...
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...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth...
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,...