Small Molecules

06 May 2019 U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease
06 May 2019 Initial Data for Alterity Therapeutics Phase 1 Clinical Trial Released at American Academy of Neurology Annual Meeting
04 May 2019 Agios Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIBSOVO® as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy
03 May 2019 Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint
02 May 2019 Genkyotex Reports Clinical Evidence of Anti-fibrotic Activity by GKT831 in Liver Fibrosis Patients
02 May 2019 Samumed Launches Phase 3 Lorecivivint (SM04690) Clinical Program in Knee Osteoarthritis
02 May 2019 Exelixis Initiating Phase 3 Pivotal Trial (COSMIC-313) of Cabozantinib in Combination with Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma
02 May 2019 Aerpio Pharmaceuticals Presents Data Showing Potential of AKB-9778, a VE-PTP Inhibitor/Tie2 Activator, to Lower Intra-ocular Pressure in Human Subjects
01 May 2019 3-V Biosciences Commences Dosing in Phase 2 Clinical Study of the FASN Inhibitor TVB-2640 in Patients with NASH
01 May 2019 TARIS Bio Initiates New Clinical Study of TAR-302 in Overactive Bladder
01 May 2019 Tetra Discovery Partners Initiates Phase 2 Clinical Trial of BPN14770 in Patients with Early Alzheimer’s Disease
01 May 2019 Eisai buys out Purdue rights to end collaboration
01 May 2019 FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
30 Apr 2019 Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA® (apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer
30 Apr 2019 Aptinyx Reports Positive Data from Phase 1 Study of Novel NMDA Receptor Modulator, NYX-458, in Healthy Volunteers
30 Apr 2019 FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
30 Apr 2019 Cerevance Achieves Key Endpoints in Phase 1 Clinical Trial of Novel Parkinson’s Disease Drug CVN424
29 Apr 2019 Cerecor Announces Positive Phase I Safety Data for CERC-801 in Healthy Volunteers
29 Apr 2019 U.S. FDA accepts New Drug Application and grants Priority Review for darolutamide
29 Apr 2019 OMEICOS Therapeutics Announces First-Dosing in Phase 2 Clinical Study Evaluating its Lead Program OMT-28 in Patients with Persistent Atrial Fibrillation
29 Apr 2019 LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion for First-Line Maintenance Treatment in BRCA-Mutated Advanced Ovarian Cancer
29 Apr 2019 ViiV Healthcare Submits New Drug Application to US FDA for the First Monthly, Injectable, Two-Drug Regimen of Cabotegravir and Rilpivirine for Treatment of HIV
28 Apr 2019 European Commission Grants Conditional Marketing Authorization for Portola Pharmaceuticals’ Ondexxya™ (andexanet alfa), the First and Only Antidote for the Reversal of Factor Xa Inhibitors
28 Apr 2019 ZynquistaTM now approved in the European Union for treatment of adults with type 1 diabetes
28 Apr 2019 ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection

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