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...
treatment News
PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.1,2 This approval is based on the results from the global Phase 3 randomized,...
PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).1 This approval is based on...
GERMANTOWN, Md — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is...
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....
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...