Small Molecules

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)
20 Nov 2018 Asceneuron Initiates Neuroimaging Trial for Tau Modifier ASN120290
20 Nov 2018 BELLUS Health Announces Positive Top-Line Phase 1 Results for its Chronic Cough Drug Candidate BLU-5937
20 Nov 2018 Denali Therapeutics Announces Positive Clinical Results With Its Lead RIPK1 Inhibitor Molecule and Intention to Initiate Patient Studies in Multiple Indications in Collaboration With Sanofi
19 Nov 2018 GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia
19 Nov 2018 Bridge Biotherapeutics Files Investigational New Drug Application for BBT-877, an Autotaxin Inhibitor for Idiopathic Pulmonary Fibrosis
19 Nov 2018 FDA Approves AEMCOLO™ (rifamycin), the First Antibiotic Approved for the Treatment of Travelers' Diarrhea in Over a Decade
19 Nov 2018 Aeterna Zentaris (AEZS) Receives Positive CHMP Opinion of Macimorelin for Diagnosis of Adult Growth Hormone Deficiency
19 Nov 2018 TRACON Pharmaceuticals Presents Data from Phase 2 Trial of TRC102 and Temodar® in Patients with Recurrent Glioblastoma at Society for Neuro-Oncology Annual Meeting
19 Nov 2018 Corcept Therapeutics Announces First Patient Dosed in Phase 3 Trial of Relacorilant to Treat Patients with Cushing’s Syndrome
18 Nov 2018 Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease
18 Nov 2018 European Medicines Agency recommends fexinidazole, the first all-oral treatment for sleeping sickness
18 Nov 2018 Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
18 Nov 2018 Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer

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