Small Molecules

08 Mar 2019 Bayer submits European marketing authorization application for darolutamide
07 Mar 2019 Helsinn initiates two new global Phase III studies with anamorelin
07 Mar 2019 Allergan Announces Phase 3 Results for Rapastinel as an Adjunctive Treatment of Major Depressive Disorder (MDD)
07 Mar 2019 PHASE 3 STUDIES OF THE TRIPLE COMBINATION OF VX-445, TEZACAFTOR AND IVACAFTOR MET PRIMARY ENDPOINT OF IMPROVEMENT IN LUNG FUNCTION (PPFEV1) IN PEOPLE WITH CYSTIC FIBROSIS
07 Mar 2019 Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy® vs. Once-Daily Truvada® for Prevention of HIV Infection
07 Mar 2019 Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance
06 Mar 2019 Kura Oncology Announces FDA Clearance of Investigational New Drug Application for Menin-MLL Inhibitor KO-539
06 Mar 2019 Ritter Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Clinical Trial of RP-G28 in Patients with Lactose Intolerance
06 Mar 2019 Janssen Announces U.S. FDA Approval of SPRAVATO™ (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief
06 Mar 2019 U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis
06 Mar 2019 FDA Accepts Genentech’s Supplemental New Drug Application for XOFLUZA (baloxavir marboxil) for the Treatment of Influenza in People at High Risk of Complications
06 Mar 2019 Mundipharma EDO GmbH Initiates Expansion Phase of First-in-human Trial to Investigate Use of Tinostamustine in Rare and Difficult-to-treat Blood Cancers
05 Mar 2019 Almirall and Athenex Announce Positive Topline Results from Two Phase III Studies of KX2-391 Ointment 1% Featured in Late Breaker Program at the 2019 American Academy of Dermatology Annual Meeting
05 Mar 2019 Odonate Therapeutics Announces Initiation of CONTESSA 2, a Phase 2 Study of Tesetaxel in Patients with Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane
04 Mar 2019 Verastem Oncology Presents Phase 3 DUO™ Data Evaluating COPIKTRA™ (Duvelisib) in Patients with CLL/SLL Who Have Progressed Following Two Prior Lines of Therapy
04 Mar 2019 BioCryst Advancing BCX9930, an Oral Factor D Inhibitor for Complement-Mediated Diseases, into Phase 1 Development
03 Mar 2019 Verrica Pharmaceuticals Presents Positive Results from Two Phase 3 Clinical Trials of VP-102 in Late-Breaking Oral Presentation at the 2019 American Academy of Dermatology Meeting
03 Mar 2019 Principia Biopharma Announces Positive Data from Phase 2 Pemphigus Vulgaris Trial at 2019 American Academy of Dermatology Annual Meeting in Late-Breaking Presentation
02 Mar 2019 Concert Pharmaceuticals Presents Interim CTP-543 Phase 2 Data in Alopecia Areata during Late-Breaker Session at American Academy of Dermatology Annual Meeting
02 Mar 2019 CHMP recommends ZynquistaTM (sotagliflozin) for the treatment of adults with type 1 diabetes
02 Mar 2019 Nektar Therapeutics Presents Preliminary Immune Activation, Safety and Clinical Activity Data from the Ongoing Dose-Escalation Stage of the REVEAL Study at 2019 ASCO-SITC Meeting
01 Mar 2019 LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion For Use in Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
01 Mar 2019 Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer
28 Feb 2019 TG Therapeutics Announces Positive Outcome from UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib in Patients with Relapsed/Refractory Marginal Zone Lymphoma
28 Feb 2019 Adamis Provides Regulatory Update on Sublingual Tadalafil

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