Blog
RSS FeedPosted by Michael Wonder on 27 Feb 2018
Lilly receives additional FDA approval for Verzenio (abemaciclib), as initial treatment for advanced breast cancer
26 February 2018 - New indication based on MONARCH 3 trial can help more women living with HR+, HER2- advanced breast ...
Posted by Michael Wonder on 26 Feb 2018
Statement from FDA Commissioner on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
26 February 2018 - The current influenza season has been especially difficult, causing widespread illness that has affected all fifty ...
Posted by Michael Wonder on 26 Feb 2018
Taking new steps to meet the challenges of rare diseases — FDA marks the 11th Rare Disease Day
26 February 2018 - Today 30 million people in the United States – or one out of every 10 Americans – ...
Posted by Michael Wonder on 26 Feb 2018
Contribution of NIH funding to new drug approvals 2010–2016
12 February 2018 - This report shows that NIH funding contributed to published research associated with every one of the 210 ...
Posted by Michael Wonder on 25 Feb 2018
Patients eagerly awaited a generic drug. Then they saw the price.
23 February 2018 - When Teva Pharmaceuticals announced recently that it would begin selling a copycat version of Syprine — ...
Posted by Michael Wonder on 24 Feb 2018
Mallinckrodt receives FDA acceptance of stannsoporfin new drug application filing
23 February 2018 - Action date set for 22 August 2018. ...
Posted by Michael Wonder on 24 Feb 2018
FDA accepts Shire’s biologics license application and grants priority review for lanadelumab for the prevention of attacks in hereditary angioedema patients
23 February 2018 - Lanadelumab, the first long-acting investigational monoclonal antibody in hereditary angioedema, is being evaluated for the prevention of ...
Posted by Michael Wonder on 24 Feb 2018
KemPharm announces FDA approval of Apadaz (benzhydrocodone and paracetamol) for the short-term management of acute pain
23 February 2018 - Apadaz is the first pro-drug of hydrocodone/paracetamol to be approved by FDA. ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 23 Feb 2018
Evofem Biosciences receives fast track designation for Amphora for prevention of Chlamydia
21 February 2018 - Evofem Biosciences today announced that the U.S. FDA has granted fast track designation for Amphora (L-lactic acid, ...
Posted by Michael Wonder on 22 Feb 2018
Developing anti-cancer drugs in orphan molecular entities — a paradigm under construction
22 February 2018 - Genomic characterisation of cancers has shown that some oncogenic alterations occur at very low frequency and are ...
Posted by Michael Wonder on 22 Feb 2018
Federal right-to-try legislation — threatening the FDA’s public health mission
22 February 2018 - A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. ...
Posted by Michael Wonder on 22 Feb 2018
FDA acceptance of Medicines360's filing for supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg
22 February 2018 - Application seeks to extend duration of use up to 5 years for Liletta. ...
Posted by Michael Wonder on 21 Feb 2018
PTC Therapeutics receives formal dispute resolution request decision from the FDA's Office of New Drugs
20 February 2018 - PTC Therapeutics today announced that the Office of New Drugs of the U.S. FDA has reiterated ...
Posted by Michael Wonder on 21 Feb 2018
Trump pushing ahead on Koch-backed experimental drugs 'right to try' agenda
21 February 2018 - The Koch brothers have already backed efforts to pass similar legislation in 38 states. ...