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RSS FeedPosted by Michael Wonder on 20 Jul 2018
FDA approves new indications for Zomacton (somatropin) as Ferring plans launch of needle-free delivery system
19 July 2018 - Ferring will launch ZOMA-Jet 10 needle-free delivery system for Zomacton in September. ...
Posted by Michael Wonder on 19 Jul 2018
Ocular Therapeutix announces FDA acceptance of NDA resubmission for Dextenza
19 July 2018 - PDUFA date is set for 28 December 2018. ...
Posted by Michael Wonder on 19 Jul 2018
Drug makers game the patent system and reap billions, FDA says
19 July 2018 - Gottlieb issues plan to boost biosimilar market, lower prices. ...
Posted by Michael Wonder on 19 Jul 2018
Lilly's once-weekly Trulicity (dulaglutide) label updated to include data showing benefits for adults with type 2 diabetes and chronic kidney disease
19 July 2018 - The U.S. label for Eli Lilly's once-weekly Trulicity (dulaglutide) is updated to show the medicine's safety and ...
Posted by Michael Wonder on 19 Jul 2018
Statement by FDA Commissioner on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
19 July 2018 - As part of our public health mission, the FDA monitors the pharmaceutical supply chain to support ...
Posted by Michael Wonder on 19 Jul 2018
FDA accepts biologics license application for filing and grants priority review for sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer
18 July 2018 - The Prescription Drug User Fee Act target action date is 18 January 2019. ...
Posted by Michael Wonder on 18 Jul 2018
FDA grants breakthrough therapy designation for Genentech’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma
17 July 2018 - Genentech today announced that the U.S. FDA has granted breakthrough therapy designation for Tecentriq (atezolizumab) in combination ...
Posted by Michael Wonder on 18 Jul 2018
Remarks from FDA Commissioner as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
18 July 2018 - Our ability to build a market for safe, effective biosimilar products is key for patients and ...
Posted by Michael Wonder on 18 Jul 2018
Novartis Kisqali now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for pre-menopausal women; and as initial therapy with fulvestrant in postmenopausal women
18 July 2018 - Kisqali is now the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment ...
Posted by Michael Wonder on 18 Jul 2018
Janssen announces U.S. FDA approval of Symtuza, the first and only complete darunavir-based single tablet regimen for the treatment of HIV-1 infection
17 July 2018 - Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the ...
Posted by Michael Wonder on 17 Jul 2018
Are 'breakthrough' drugs as safe as other FDA approved medicines?
17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA. ...
Posted by Michael Wonder on 17 Jul 2018
Congress ready to forbid drug price 'gag clauses' against pharmacies
16 July 2018 - Senator Susan Collins of Maine on Monday said Congress is ready and able to forbid “gag ...
Posted by Michael Wonder on 17 Jul 2018
Statement from FDA Commissioner on new efforts to empower consumers by advancing access to nonprescription drugs
17 July 2018 - At the FDA, we’re continuing to look at ways we can foster greater access to the ...
Posted by Michael Wonder on 17 Jul 2018
AbbVie announces Humira (adalimumab) patent license with Mylan
17 July 2018 - AbbVie announced today patent license agreements with Mylan over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 16 Jul 2018
Tonix Pharmaceuticals receives fast track designation from the U.S. FDA for TNX-102 SL for treatment of agitation in Alzheimer’s disease
16 July 2018 - Tonix Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its investigational new ...