Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2018
U.S. FDA approves Xtandi (enzalutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer
13 July 2018 - First and only oral treatment FDA approved for both non-metastatic and metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 13 Jul 2018
FDA budget matters: investing in advanced domestic manufacturing
13 July 2018 - There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring ...
Posted by Michael Wonder on 13 Jul 2018
Amgen and UCB resubmit biologics license application for Evenity (romosozumab) to the US FDA
12 July 2018 - Application includes data from pivotal Phase 3 studies of more than 11,000 patients. ...
Posted by Michael Wonder on 13 Jul 2018
FDA approves the first drug with an indication for treatment of smallpox
13 July 2018 - The U.S. FDA today approved Tpoxx (tecovirimat), the first drug with an indication for treatment of smallpox. ...
Posted by Michael Wonder on 13 Jul 2018
PhRMA statement on efforts to support real world evidence
12 July 2018 - PhRMA spokesperson Andrew Powaleny issued the following statement on comments made by U.S. FDA Commissioner Scott Gottlieb. ...
Posted by Michael Wonder on 12 Jul 2018
Statement by FDA Commissioner on the formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
12 July 2018 - We’ve seen the number of new drug shortages steadily decline since a peak in 2011 owing to ...
Posted by Michael Wonder on 12 Jul 2018
AbbVie announces submission of supplemental new drug application to US FDA for venetoclax in newly diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
12 July 2018 - The US FDA has granted venetoclax two breakthrough therapy designations in acute myeloid leukaemia, which are ...
Posted by Michael Wonder on 11 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of patients with advanced hepatocellular carcinoma
11 July 2018 - Application based on monotherapy data from phase 2 KEYNOTE-224 trial. ...
Posted by Michael Wonder on 11 Jul 2018
FDA accepts biologics license application for subcutaneous formulation of Herceptin
11 July 2018 - Halozyme Therapeutics today announced that the U.S. FDA has accepted a biologics license application from Genentech, a ...
Posted by Michael Wonder on 11 Jul 2018
Statement from FDA Commissioner on agency’s efforts to advance development of gene therapies
11 July 2018 - Once just a theory, gene therapies are now a therapeutic reality for some patients. ...
Posted by Michael Wonder on 11 Jul 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) & low-dose Yervoy (ipilimumab) is the first immuno-oncology combination approved for MSI-H/dMMR mCRC patients who progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
11 July 2018 - Opdivo & Yervoy is now approved in three tumour types, dosing and administration varies by tumour. ...
Posted by Michael Wonder on 11 Jul 2018
Could FDA use off-label data for drug approvals? It’s possible, agency official says
10 July 2018 - The FDA might one day use data gathered from off-label uses of drugs to determine whether ...
Posted by Michael Wonder on 10 Jul 2018
Brett Kavanaugh, Trump’s pick for court, has left trail of opinions on health care and pharma issues
10 July 2018 - Brett Kavanaugh, President Trump’s nominee for the Supreme Court, has left a trail of rulings and ...
Posted by Michael Wonder on 10 Jul 2018
FDA budget matters: a cross-cutting data enterprise for real world evidence
10 July 2018 - Over time, as our experience with new medical products expands, our knowledge about how best to maximise ...
Posted by Michael Wonder on 10 Jul 2018
FDA grants fast track designation to Aclaris Therapeutics’ investigational JAK inhibitor for the treatment of alopecia areata
9 July 2018 - Aclaris Therapeutics announced today that the U.S. FDA has granted fast track designation to Aclaris’ investigational topical ...