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RSS FeedPosted by Michael Wonder on 25 Feb 2016
Pfizer announces FDA approval of Xeljanz XR (tofacitinib citrate) extended-release tablets, the first and only once-daily oral JAK inhibitor treatment for rheumatoid arthritis
24 February 2016 - Pfizer Inc. announced today that the U.S. FDA has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg ...
Posted by Michael Wonder on 24 Feb 2016
FDA accepts and grants priority review for Avycaz (ceftazidime and avibactam) supplemental new drug application
24 February 2016 - This filing will add important new clinical data to the current label from two Phase III trials ...
Posted by Michael Wonder on 24 Feb 2016
FDA releases online continuing education course on biosimilars
18 February 2016 - The 90 minute course shares important information about the new type of biological product to help health ...
Posted by Michael Wonder on 24 Feb 2016
FDA statement on Senate confirmation of Dr. Robert M. Califf
24 February 2016 - Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to ...
Posted by Michael Wonder on 23 Feb 2016
PTC receives refuse to file letter from FDA for Translarna (ataluren)
23 February 2016 - The FDA states in the Refuse to File letter that the application was not sufficiently complete to ...
Posted by Michael Wonder on 19 Feb 2016
FDA approves Briviact to treat partial onset seizures
19 February 2016 - The U.S. FDA yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial ...
Posted by Michael Wonder on 09 Feb 2016
FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality
9 February 2016 - The U.S. FDA is requesting a total budget of $5.1 billion to protect and promote the public ...
Posted by Michael Wonder on 04 Feb 2016
Califf, FDA top officials call for sweeping review of agency opioids policies
4 February 2016 - In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical ...
Posted by Michael Wonder on 02 Feb 2016
FDA grants fast track designation to Ryanodex for treatment of exertional heat stroke; fast track designation highlights serious, unmet medical need that exists for patients with EHS
1 February 2016 - The FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions ...
Posted by Michael Wonder on 28 Jan 2016
FDA approves first drug to show survival benefit in liposarcoma
28 January 2016 - The U.S. FDA today approved Halaven (eribulin mesylate) for the treatment of liposarcoma (a specific type of ...
Posted by Michael Wonder on 27 Jan 2016
Progress and collaboration on clinical trials
14 January 2016 - Last year, FDA took important steps to support the inclusion of diverse populations in clinical trials. ...
Posted 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 ...