Invokana Gets FDA’s Priority Review for CKD in T2D Indication By Diana Ernst, RPh Publish Date May 22, 2019
Oral Plasma Kallikrein Inhibitor Prevents HAE Attacks in Phase 3 Trial By Steve Duffy Publish Date May 21, 2019
Inclisiran Associated With Sustained LDL-C Reduction in ORION-3 Study By Steve Duffy Publish Date May 20, 2019
NDA for Twirla Contraceptive Patch Resubmitted to FDA By Brian Park, PharmD Publish Date May 20, 2019
Abrocitinib Looks Promising in Phase 3 Atopic Dermatitis Trial By Diana Ernst, RPh Publish Date May 15, 2019
FDA Panel Backs Pexidartinib for Rare Tumor, Votes Against Quizartinib for FLT3-ITD AML By Diana Ernst, RPh Publish Date May 15, 2019
Relugolix Combination Therapy Effective in Phase 3 Uterine Fibroids Trial By Steve Duffy Publish Date May 14, 2019
Kaposi Sarcoma Treatment Gets Breakthrough Therapy Designation By Steve Duffy Publish Date May 13, 2019
Novel Treatment for Schizophrenia Gets FDA’s Breakthrough Therapy Designation By Diana Ernst, RPh Publish Date May 10, 2019
BLA for Subcutaneous Formulation of Vedolizumab Submitted for FDA Review By Diana Ernst, RPh Publish Date May 9, 2019
Ryaltris Safe, Effective for Pediatric Patients in Seasonal Allergic Rhinitis Trial By Diana Ernst, RPh Publish Date May 8, 2019
CBD Gel Gets Fast Tracked for Behavioral Symptoms Associated With Fragile X Syndrome By Steve Duffy Publish Date May 7, 2019
Inhaled Molgramostim Granted Fast Track Status for Autoimmune Pulmonary Alveolar Proteinosis By Steve Duffy Publish Date May 6, 2019
FDA Passes on Barhemsys NDA Again Due to Facility Issues By Diana Ernst, RPh Publish Date May 3, 2019
Trelegy Ellipta Improves Lung Function in Patients With Uncontrolled Asthma By Diana Ernst, RPh Publish Date May 2, 2019
Facility Inspections, Manufacturing Deficiencies Hinder Approval of Contepo, According to FDA’s CRL By Steve Duffy Publish Date May 1, 2019
Microbiota Transfer Therapy Gets Fast-Tracked for ASD Treatment By Steve Duffy Publish Date April 30, 2019
Darolutamide Gets Priority Review for Non-Metastatic Castration-Resistant Prostate Cancer By Steve Duffy Publish Date April 29, 2019
NDA for Once-Monthly Injectable HIV Treatment Submitted to FDA By Diana Ernst, RPh Publish Date April 29, 2019
