Novartis announced today that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation is…
Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the…
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) as an add-on maintenance therapy for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), the first subcutaneous (SC) PD-(L)1 inhibitor for cancer treatment in the United States. This new formulation can be…
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved EBGLYSS™ (lebrikizumab-lbkz), an IL-13 inhibitor, for treating moderate-to-severe atopic dermatitis (eczema) in adults and children aged 12 and older who weigh at least…
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has announced that the Ministry of Health, Labour and Welfare (MHLW) has approved Alecensa® (generic name: alectinib) for the additional indication of “adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer” in Japan.…
Invenra Inc. is excited to announce that its cutting-edge bispecific antibody, INV724, designed for neuroblastoma treatment, has received both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations from the U.S. Food and Drug Administration (FDA). These designations offer significant…
GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to GSK5764227 (GSK’227), an investigational B7-H3-targeted antibody-drug conjugate (ADC) being studied for the treatment of patients with extensive-stage small-cell lung cancer…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for their COMIRNATY® COVID-19 vaccine for individuals aged 12 and older. The FDA has…
Bristol Myers Squibb (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as a potential first-line treatment for adults with unresectable…
Medea Inc., a leading medical products and pharmaceutical distribution company, is at the forefront of a major initiative to tackle the opioid crisis. The company is partnering with CalOptima Health to distribute 100,000 units of naloxone nasal spray to harm…