Small Molecules

29 Nov 2018 FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
29 Nov 2018 XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation
29 Nov 2018 Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe
28 Nov 2018 ONO Submits an Application for Manufacturing and Marketing Approval of Anamorelin (ONO-7643), a ghrelin receptor antagonist, for the treatment of cancer cachexia in Japan
28 Nov 2018 Melinta Therapeutics Granted European Commission Marketing Authorization for Vabomere® (meropenem and vaborbactam)
28 Nov 2018 Primary endpoint met in phase III clinical study of Fycompa® as monotherapy for partial-onset seizures aiming for submission in Japan
28 Nov 2018 Cytokinetics Completes Enrollment in FORTITUDE-ALS, Phase 2 Clinical Trial of Reldesemtiv in Patients With ALS
28 Nov 2018 European Commission Approves ALUNBRIG® (brigatinib) for ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib, Advancing Treatment Paradigm in Europe
28 Nov 2018 Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
27 Nov 2018 Spirita Oncology, LLC Initiates a Phase 1 Clinical Trial of the Anti-Cancer Agent E6201 in Patients with Central Nervous System Metastases from BRAF+ or MEK-Mutated Metastatic Melanoma
27 Nov 2018 MicuRx Enrolls First Patient in a Phase 2 Clinical Trial in U.S. for Novel Antibiotic, Contezolid Acefosamil
27 Nov 2018 Aptose Biosciences Doses First Patient in Re-Initiation of Phase 1b Clinical Study of APTO-253 in Relapsed or Refractory Hematological Malignancies
27 Nov 2018 G1 Therapeutics Announces Positive Myelopreservation Data from Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Trilaciclib in Combination with Chemotherapy/Tecentriq® in First-Line Small Cell Lung Cancer
27 Nov 2018 FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)
27 Nov 2018 Vectura announces results for late stage clinical asset VR475 in severe uncontrolled asthma
27 Nov 2018 Zafgen Provides Update on Investigational New Drug Application for ZGN-1061
22 Nov 2018 Camurus Receives EU Approval for Weekly and Monthly Buvidal® (CAM2038) for Opioid Dependence
22 Nov 2018 Oasmia Pharmaceutical Receives Approval from European Commission for Apealea® (paclitaxel micellar) in the European Union
22 Nov 2018 U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option
22 Nov 2018 Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible for Intensive Induction Chemotherapy
21 Nov 2018 Blueberry Therapeutics Limited Announce Positive Results from a Phase I/II Clinical Trial
21 Nov 2018 FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
21 Nov 2018 Theravance Biopharma Announces First Patient Dosed in Phase 2 Study of TD-1473 in Patients with Crohn's Disease
21 Nov 2018 Collaboration to evaluate ZEN-3694 in combination with Talazoparib in TNBC patients; Phase 1b/2 trial expected to initiate 1Q 2019
20 Nov 2018 Ipsen and 3BP announce First Patient Dosed in Phase I/II study for first-in-class radionuclide (IPN01087)

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