Apr 17, 2020
FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts
Mar 31, 2020
MEI Pharma Announces Fast Track Designation Granted by U.S. FDA for ME-401 For the Treatment of Adult Patients with Relapsed or Refractory Follicular Lymphoma
Jan 23, 2020
FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
Dec 12, 2019
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation
Nov 25, 2019
FDA approves novel treatment to target abnormality in sickle cell disease
Oct 31, 2019
IDEAYA Biosciences Reports End-of-Phase 1 Meeting with FDA for IDE196 Confirms Acceptability of Single-Arm Trial Design for Potential Phase 2 Registration-Enabling Study in Metastatic Uveal Melanoma
Oct 22, 2019
BerGenBio Receives FDA Approval of Fast Track Designation for Bemcentinib
Aug 02, 2019
FDA approves first therapy for rare joint tumor
Jun 05, 2019
Sierra Announces Momelotinib Granted FDA Fast Track Designation
Apr 18, 2019
Moleculin Receives FDA Approval of Fast Track Designation for Annamycin
Apr 16, 2019
Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)
Apr 11, 2019
FDAnews Announces -- The Accelerated Approval Pathway for Drugs and Biologics: Final Labeling Guidance Webinar, April 25, 2019
Mar 26, 2019
Diamyd Medical Announces Strategic Activities for 2019 and 2020
Mar 12, 2019
FDA In Brief: FDA takes new steps to broaden patient participation in cancer clinical trials, advancing policies to promote inclusion of pediatric patients and patients with medical conditions that can occur alongside cancer
Feb 14, 2018
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
Dec 26, 2017
DelMar Pharmaceuticals Announces Fast Track Designation for VAL-083 in Recurrent Glioblastoma
Nov 30, 2017
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, "Implementing the 21st Century Cures Act: An Update from FDA and NIH"
Aug 29, 2017
FDA approves first U.S. treatment for Chagas disease