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…
Alzamend Neuro, a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, announced its partnership with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of…
The “U.S. Oligonucleotide Synthesis Market Size, Share & Trends Analysis Report” for 2024-2030 has been added to ResearchAndMarkets.com’s portfolio. This report forecasts that the U.S. oligonucleotide synthesis market will reach USD 3.09 billion by 2030, growing at a CAGR of…
Agilent has announced that it has received FDA approval for the MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to identify patients with synovial sarcoma who may qualify for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or…
Vertex Announces FDA Acceptance of Suzetrigine NDA for Acute Pain Vertex Pharmaceuticals today revealed that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for suzetrigine, an investigational oral NaV1.8 pain signal inhibitor designed to…
Novartis announced that the US Food and Drug Administration (FDA) has granted Priority Review status to Scemblix® (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The FDA’s Priority…
Global pharmaceutical leader Lupin Limited (Lupin) has announced the approval of its Abbreviated New Drug Application by the United States Food and Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules. This approval covers dosages of 25 mg, 50 mg, 100…
Today, AbbVie announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication for upadacitinib (RINVOQ®; 15 mg, once daily) to treat adult patients with giant cell…
Daiichi Sankyo (TSE: 4568) has inaugurated a new affiliate dedicated to its oncology business in Athens, Greece, underscoring its commitment to addressing the needs of cancer patients in Europe. Thomais Konstantopoulou has been appointed as the Country Manager for Daiichi…