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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Jul 2018
Enzyvant announces initiation of RVT-802 rolling BLA submission for the treatment of complete DiGeorge anomaly
9 July 2018 - Completion of rolling BLA submission anticipated by end of 2018. ...
Posted by Michael Wonder on 09 Jul 2018
Statement by FDA Commissioner on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
9 July 2018 - The opioid epidemic continues to take an emotional, physical and financial toll on Americans. The U.S. ...
Posted by Michael Wonder on 07 Jul 2018
FDA takes steps to encourage more informative labelling on prescription drug and biological products’ indications and usage
6 July 2018 - Today, the U.S. Food and Drug Administration issued a draft guidance to provide recommendations for consideration ...
Posted by Michael Wonder on 05 Jul 2018
A risky drug approval lesson
4 July 2018 - What the FDA can learn from progress against muscular dystrophy. ...
Posted by Michael Wonder on 05 Jul 2018
Theratechnologies submits novel single-vial formulation of Egrifta (tesamorelin for injection) for FDA approval
4 July 2018 - Theratechnologies today announced that it has filed a supplemental new drug application with the FDA for ...
Posted by Michael Wonder on 04 Jul 2018
FDA approves Xeomin (incobotulinumtoxina) for adult patients with sialorrhoea
3 July 2018 - First and only neurotoxin approved for this indication in the United States. ...