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…
Incyte (Nasdaq: INCY) today reported positive results from the pivotal Phase 3 inMIND study, which evaluated the efficacy and safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19-targeted monoclonal antibody, in combination with lenalidomide and rituximab, versus placebo combined with…
Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK), a leading innovation-driven pharmaceutical company in China, and Guangzhou Lupeng Pharmaceutical Co., Ltd. (Lupeng Pharma), which specializes in treatments for malignant tumors and autoimmune diseases, have announced a licensing agreement for LP-168,…
Today, the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for treating ADAMTS13 deficiency in both children and adults with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is now the first and only enzyme replacement therapy in the European Union (EU) specifically…
Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta® (iptacopan), a first-in-class complement inhibitor designed to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This…