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llllllllll Rozlytrek (entrectinib) / RocheRozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer (Roche Press Release) - Aug 3, 2020 - "Roche...announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors."llllllllll Spravato (esketamine intranasal) / J&JJanssen Announces U.S. FDA Approval of SPRAVATO (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior (PRNewswire) - Aug 3, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior....SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors."llllllllll racemetyrosine (SM-88) / TymeTYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer (Businesswire) - Aug 3, 2020 - "Tyme Technologies, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug Designation for its lead pipeline candidate, SM-88 (racemetyrosine), as a potential treatment for patients with pancreatic cancer."llllllllll Cosentyx (secukinumab) / NovartisNovartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis (GlobeNewswire) - Aug 3, 2020 - "Novartis...today announced the European Commission (EC) has granted the approval for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to
