ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myeloma RARITAN, N.J. — Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic...
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PLYMOUTH MEETING, Pa. — INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the FDA has notified INOVIO that it agrees with its rolling submission timeline for the BLA for...
BOSTON, Mass. and SURESNES, France — Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the...
Washington, DC – The 2023 US Food and Drug Administration approval of omaveloxolone (Skyclarys®) for the treatment of Friedreich ataxia (FA) in patients aged 16 or more years was a significant step forward for the FA community. Omaveloxolone promotes improved mitochondrial function and boosts antioxidant activity—but it does not offer...
Recently completed medical research could lead to the first ever FDA approved drugs for FSGS and IgA Nephropathy—two conditions with dismal prognoses using current interventions. Nephrology Associates of Northern Illinois and Indiana (NANI) physicians and researchers nationwide collaborated on groundbreaking studies. IgA Nephropathy (IgAN) is an autoimmune disease that affects the kidneys...
EAST HANOVER, N.J. — Novartis announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy...
The U.S. Food and Drug Administration (FDA) today approved an imaging drug known as Cytalux (pafolacianine), which is attracted to ovarian cancer tissue and illuminates it when exposed to fluorescent light, allowing surgeons to more easily find and more precisely remove the cancer. Physicians at the Center for Precision Surgery in the Abramson Cancer Center...
FDA has approved Evkeeza (evinacumab-dgnb) injection as an add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. HoFH is a rare, life-threatening condition that occurs in approximately 1 in 250,000 individuals. Patients with HoFH have two mutations in a...
WALTHAM, Mass. — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary...
CAMBRIDGE, Mass. – Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL)....