Blog
RSS FeedPosted by Michael Wonder on 01 Mar 2016
Promoting therapeutic innovation: what do we do about drug-device combinations?
2 March 2016 - There’s been a heated debate over the past year over whether legislative incentives are needed to encourage ...
Posted by Michael Wonder on 29 Feb 2016
FDA providing $2 million in new grants for natural history studies in rare diseases
29 February 2016 - The U.S. FDA today announced the availability of $2 million in research grants to fund natural history ...
Posted by Michael Wonder on 28 Feb 2016
Ask your doctor if this ad is right for you
28 Febraury 2016 - How advertising promotes expensive drugs and treatments you may not need. ...
Posted by Michael Wonder on 27 Feb 2016
FDA approves new option for certain people with previously treated follicular lymphoma
26 February 2016 - the FDA has approved Gazyva (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyva alone as a ...
Posted by Michael Wonder on 26 Feb 2016
FDA approves new indication for Novartis drug Afinitor for progressive, non-functional gastro-intestinal and lung neuroendocrine tumors
26 February 2016 - Novartis today announced that the United States FDA approved Afinitor (everolimus) tablets for the treatment of adult ...
Posted by Michael Wonder on 26 Feb 2016
Allergan announces FDA approval of Aczone (dapsone) 7.5% topical gel for treatment of acne vulgaris
25 February 2016 - Allergan plc today announced that the Company has received approval from the U.S. FDA to market Aczone ...
Posted by Michael Wonder on 25 Feb 2016
Pfizer receives expanded FDA approval for Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
19 February 2016 - Ibrance is now approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced ...
Posted 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 ...