May 15, 2020
Blueprint Medicines Receives Complete Response Letter from FDA for Avapritinib New Drug Application for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
Apr 16, 2020
Science and Technology Daily: Chinese Approach on Medical Treatment against COVID-19
Jan 08, 2020
AMCP Format for Formulary Submissions, Version 4.1, Includes New Dossiers for Submitting Evidence on Unapproved Medicines and Unapproved Indications Submitted for FDA Approval
Jan 07, 2020
IceCure Receives FDA Clearance for Expanded Indications of Cryoablation Technology and Regulatory Approval of New MultiSense System; Plans to Increase U.S. Presence and Operations
Nov 05, 2019
Blueprint Medicines Outlines Precision Therapy Research Vision, Provides Update on Discovery and Clinical-Stage Portfolio at R&D Day and Reports Third Quarter 2019 Financial Results
Oct 02, 2019
DURECT Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain
Sep 24, 2019
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
Sep 13, 2019
Statement from FDA's Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine
Aug 28, 2019
Veterinary Drug Approval Process and FDA Regulatory Course: Chicago, IL, United States - December 5-6, 2019
Aug 28, 2019
Two Day Veterinary Drug Approval Process and FDA Regulatory Oversight Seminar: Kansas City, United States - September 26-27, 2019
Aug 20, 2019
Global Syndromic Testing Markets, 2018-2023 - Continued Unnecessary Antibiotic Prescription Use
Aug 19, 2019
Sheba Researchers Find Significant Improvements in Patient Safety Standard Following Deployment of MedAware's Machine Learning-based Platform
Jul 17, 2019
DURECT Announces that the FDA Agreed to File the Full Response to the POSIMIR® Complete Response Letter as a Complete Class 2 Resubmission
Jun 27, 2019
DURECT Announces Submission to FDA of a Full Response to the POSIMIR® Complete Response Letter
Apr 11, 2019
FDA orders important safety labeling changes for Addyi
Apr 11, 2019
FDAnews Announces -- The Accelerated Approval Pathway for Drugs and Biologics: Final Labeling Guidance Webinar, April 25, 2019
Jan 17, 2019
Focus on Personalized Cancer Treatment Drives the Pharmacogenomics (PGx) Labelling of Oncology Drugs
Dec 06, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA's new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products