Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2018
BeiGene announces plan to pursue accelerated approval in the U.S. of BTK inhibitor zanubrutinib in Waldenström macroglobulinaemia
22 July 2018 - Fast track designation granted by U.S. FDA. ...
Posted by Michael Wonder on 22 Jul 2018
US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria
20 July 2018 - First single-dose medicine to prevent the relapse of P. vivax malaria marks a major contribution towards ...
Posted by Michael Wonder on 20 Jul 2018
Sellas receives fast track designation from FDA for galinpepimut-S for the treatment of patients with multiple myeloma
20 July 2018 - Sellas Life Sciences today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 20 Jul 2018
U.S. FDA approves Pfizer's biosimilar Nivestym (filgrastim-aafi)
20 July 2018 - Nivestym, a biosimilar to Neupogen (filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA. ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 20 Jul 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukeamia who have a certain genetic mutation
20 July 2018 - The U.S. FDA today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or ...
Posted 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 ...