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Small Molecules

01 Nov 2018 Galapagos reports initiation of PINTA Phase 2 trial with GLPG1205 in patients with Idiopathic Pulmonary Fibrosis (IPF)
31 Oct 2018 FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
31 Oct 2018 Rgenix Treats First Patient in Phase 1 Trial of RGX-202
31 Oct 2018 U.S. FDA Approves INVOKANA® (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
31 Oct 2018 Janssen Presents Positive Long-Term Efficacy and Safety of SYMTUZA® in Treatment-Naïve Adults with HIV-1
31 Oct 2018 Mirati Therapeutics Announces Submission of IND Application for MRTX849, a KRAS G12C Inhibitor, to Treat Non-Small Cell Lung Cancer and Colorectal Cancer
31 Oct 2018 CymaBay Announces the Initiation of the Seladelpar Global Phase 3 Registration Study (ENHANCE) for the Treatment of Primary Biliary Cholangitis and Additional Corporate Updates
31 Oct 2018 GSK announces positive phase 3 results for daprodustat in patients with anaemia associated with chronic kidney disease
31 Oct 2018 ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen
30 Oct 2018 Astellas Receives European Approval for XTANDI™ (enzalutamide) for Adult Men with High-Risk Non- Metastatic Castration-Resistant Prostate Cancer
30 Oct 2018 Goldfinch Bio Announces GFB-887 as Clinical Development Candidate and Presents Data Demonstrating Selective Inhibition of TRPC5 for the Treatment of Genetically-driven Kidney Disease
30 Oct 2018 Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the American Academy of Ophthalmology 2018 Annual Meeting
30 Oct 2018 Jazz Pharmaceuticals Announces FDA Approval of Xyrem® (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients
30 Oct 2018 Melinta Therapeutics Announces Positive Top-Line Results in Phase III Trial of Baxdela® (delafloxacin) for Treatment of CABP
30 Oct 2018 Acer Therapeutics Submits NDA for EDSIVO™ for the Treatment of vEDS
30 Oct 2018 TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
29 Oct 2018 Esperion Announces Positive Top-Line Results from Final Pivotal Phase 3 Study of Bempedoic Acid
29 Oct 2018 Novartis announces clinical collaboration with Pfizer to advance the treatment of NASH
28 Oct 2018 Ultragenyx Announces Negative Topline Results from Phase 3 Study of UX007 in Patients with Glut1 DS with Disabling Movement Disorders
26 Oct 2018 FDA Accepts Supplemental New Drug Application for LONSURF® (trifluridine/tipiracil) for the Treatment of Metastatic Gastric/Gastroesophageal Junction (GEJ) Adenocarcinoma; Grants Priority Review
25 Oct 2018 Lundbeck updates on clinical phase III study for Lu AF35700 in Treatment-Resistant Schizophrenia
25 Oct 2018 Oyster Point Announces Positive Results From Two Separate Phase 2b Clinical Trials of the Company’s Investigational Treatments for Dry Eye Disease
25 Oct 2018 Cortexyme Announces Phase 1 Data Demonstrating COR388 is Safe and Well Tolerated in Healthy Older Volunteers and Alzheimer’s Patients
25 Oct 2018 Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza
25 Oct 2018 FDA Grants Priority Review for Ruxolitinib (Jakafi®) as a Treatment for Patients with Acute Graft-Versus-Host Disease

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