Blueprint Medicines Does Not Receive Approval from FDA for Avapritinib for Treatment of 4L GIST
Blueprint Medicines Does Not Receive Approval from FDA for Avapritinib for Treatment of 4L GIST.
FDA Approves Use of Two Anti-Malaria Drugs for Coronavirus
As the number of people who have fallen ill grows, the FDA announced approval if the use of two anti-malaria drugs for coronavirus.
FDA Oncology Center of Excellence Message
In this critical time, the FDA Oncology Center of Excellence wants you to know that we are here for patients with cancer and their health care providers and we will do everything we can to help you through the coronavirus crisis.
Vitrakvi Approved
New Drug Approved for Patients with Rare Gene Fusion By Sara Rothschild, MPH, Vice President, Program Services & Jerry Call, Data Analyst The Food and Drug Administration granted accelerated approval on November 26th to [...]
LRG Discusses Importance of Real World Evidence in GIST Research at the FDA
On April 6th, 2018, Executive Director, Norman Scherzer; Data Analyst, Jerry Call; Real World Evidence Scientist, Yu Wang, and Patient Registry Director, Denisse Montoya, of The Life Raft Group, were invited to present at [...]
Generic Imatinib Approved in the US for CML: What does it mean for GIST patients?
On February 1, 2016, the commercial launch of the generic version of imatinib mesylate (Gleevec), for CML (Chronic Myeloid Leukemia) was approved by the FDA after the Novartis patent expiration and will become available for the first time in the United States through Sun Pharmaceuticals.
Encouraging Rare Disease Connections at the NORD Conference
The National Organization for Rare Diseases (NORD) held its 2015 Breakthrough Summit October 21-22 in Arlington, Virginia. This year’s event convened top leaders from the FDA, NIH, Industry, Patient Groups, Payers and Research Institutions to [...]
Former FDA Official Discusses Off-Label Use
In an online article, Peter Pitts, a former FDA associate commissioner, discussed the topic of off-label product claims by pharmaceutical companies. Off-label use in this case refers to using a medication for an intention [...]
Understanding Generic Drugs
With the onset of the patent expiration on Gleevec of the patent expiration on Gleevec for CML expiring in July and for GIST in June 2022 in the United States, it becomes more important than ever [...]
FDA Supports Patient Perspective to Promote Pharmaceutical Innovation
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research spoke to the House of Representatives about patient perspective.