Small Molecules

01 Aug 2017 Cycle Pharmaceuticals Receives FDA Approval of NityrTM (nitisinone) Tablets for Treatment of HT-1
01 Aug 2017 FDA Approves KALYDECO(R) (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
01 Aug 2017 FDA Grants Approval of IDHIFA®, the First Oral Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH2 Mutation
01 Aug 2017 Kitov Submits New Drug Application to FDA for KIT-302
01 Aug 2017 First Human Subject Enrolled in Lumosa Therapeutics' Phase 1 Trial for LT3001, a New Drug Molecule for Acute Ischemic Stroke
01 Aug 2017 Proteostasis Therapeutics Announces Progression of PTI-428 and PTI-801 to Longer Duration Studies in CF Subjects
01 Aug 2017 CTI BioPharma Announces First Patient Enrolled in Phase 2 Trial of Pacritinib in Patients with Myelofibrosis who have Thrombocytopenia and who have been Previously Treated with Ruxolitinib
01 Aug 2017 Acalabrutinib granted Breakthrough Therapy Designation by US FDA for the treatment of patients with mantle cell lymphoma
31 Jul 2017 Indivior PLC Announces FDA Acceptance with Priority Review Designation of RBP-6000 Buprenorphine Monthly Depot New Drug Application (NDA) for the Treatment of Opioid Use Disorder
31 Jul 2017 CONTROL Trial Shows Statin Therapy Reversed LDL Increases to Below Baseline Levels in NASH Patients Treated with OCA
31 Jul 2017 Intercept Announces Positive Results from the Phase 2 AESOP Trial Evaluating OCA for the Treatment of Patients with Primary Sclerosing Cholangitis
31 Jul 2017 Pain Therapeutics Announces FDA Has Cleared an Investigational New Drug (IND) Application for PTI-125
31 Jul 2017 PellePharm Announces Topline Results from Phase 2 Study of Topical Patidegib in Gorlin Syndrome Basal Cell Carcinomas and Third Closing of a $20 Million Series B Financing
31 Jul 2017 Biohaven Initiates Second Pivotal Phase 3 Clinical Trial of Oral CGRP Antagonist for the Acute Treatment of Migraine
29 Jul 2017 ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
29 Jul 2017 European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C
29 Jul 2017 ACT-541468 (DORA) meets primary endpoint in Phase 2 program in adult and elderly patients with insomnia
29 Jul 2017 European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
29 Jul 2017 FDA grants breakthrough therapy designation for Venclexta in acute myeloid leukaemia
27 Jul 2017 NewLink Genetics Announces First Patient Dosed in Phase 1 Study of IDO Pathway Inhibitor NLG802
27 Jul 2017 Aradigm Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis
27 Jul 2017 Samumed Successfully Completed 52-Week Phase 2 Study for Treatment of Osteoarthritis of the Knee
27 Jul 2017 Cytokinetics Announces Start of FORTITUDE-ALS, a Phase 2 Clinical Trial of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis
27 Jul 2017 FDA Approves Eisai's FYCOMPA® (perampanel) for Use as Monotherapy for the Treatment of Partial-Onset Seizures
27 Jul 2017 Tagrisso significantly improves progression-free survival in the Phase III FLAURA trial for lung cancer

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