Blog
RSS FeedPosted by Michael Wonder on 27 Jan 2016
Drug trials snapshots: Uptravi
26 January 2016 - The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval ...
Posted by Michael Wonder on 27 Jan 2016
2016: the year of diversity in clinical trials
27 January 2016 - In 2016, the Agency is planning a variety of activities to push for greater inclusion, including ...
Posted by Michael Wonder on 20 Jan 2016
From our perspective: Expedited oncology drug approvals
19 January 2016 - Richard Pazdur, M.D., Director of the FDA's Office of Hematology and Oncology Products, highlights some of his ...
Posted by Michael Wonder on 04 Jan 2016
2015: another strong year for patients in need of new drug therapies
4 January 2016 - In 2015, FDA’s CDER approved 45 novel new therapies – significantly more than the average of 28 ...
Posted by Michael Wonder on 22 Dec 2015
FDA approves Zurampic to treat high blood uric acid levels associated with gout
22 December 2015 - The U.S. FDA today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood ...
Posted by Michael Wonder on 22 Dec 2015
FDA approves new orphan drug to treat pulmonary arterial hypertension
22 December 2015 - On December 21, the U.S. FDA approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension ...
Posted by Michael Wonder on 17 Dec 2015
FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes
16 December 2015 - The U.S. FDA today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic ...
Posted by Michael Wonder on 15 Dec 2015
FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery
15 December 2015 - The U.S. FDA today approved Bridion (sugammadex sodium) injection to reverse the effects of neuromuscular blockade induced ...
Posted by Michael Wonder on 13 Dec 2015
FDA approves new oral therapy to treat ALK-positive lung cancer
11 December 2015 - The U.S. FDA today approved Alecensa (alectinib hydrochloride) to treat people with advanced (metastatic) ALK-positive non-small cell ...
Posted by Michael Wonder on 13 Dec 2015
FDA approves first emergency treatment for overdose of certain types of chemotherapy
11 December 2015 - The U.S. FDA today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who ...
Posted by Michael Wonder on 08 Dec 2015
FDA approves first recombinant von Willebrand factor to treat bleeding episodes
8 December 2015 - Vonvendi is the first FDA approved recombinant von Willebrand factor, and is approved for the on-demand (as ...
Posted by Michael Wonder on 08 Dec 2015
FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
8 December 2015 - Today, the U.S. FDA approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare ...
Posted by Michael Wonder on 05 Dec 2015
Best practices for communication between IND sponsors and FDA during drug development
4 December 2015 - The purpose of the draft guidance is to describe best practices and procedures for timely, transparent, ...
Posted by Michael Wonder on 30 Nov 2015
FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma
30 November 2015 - Today the U.S. FDA granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat ...
Posted by Michael Wonder on 25 Nov 2015
FDA approves Portrazza to treat advanced squamous non-small cell lung cancer
24 November 2015 - The U.S. FDA today approved Portrazza (necitumumab) for use in combination with two forms of chemotherapy to ...