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RSS FeedPosted by Michael Wonder on 02 Dec 2017
Arog Pharmaceuticals receives FDA fast track designation for crenolanib in relapsed or refractory FLT3-positive AML
1 December 2017 - Arog Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for crenolanib for ...
Posted by Michael Wonder on 02 Dec 2017
FDA approves Amgen's Repatha (evolocumab) to prevent heart attack and stroke
1 December 2017 - Following FDA priority review, Repatha is the only PCSK9 inhibitor approved to reduce risk of heart attack, ...
Posted by Michael Wonder on 02 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
1 December 2017 - The U.S. FDA today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment ...
Posted by Michael Wonder on 02 Dec 2017
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of active psoriatic arthritis
1 December 2017 - Psoriatic arthritis is the second approved indication for Taltz in the United States. ...
Posted by Michael Wonder on 01 Dec 2017
FDA aims to expand early approval program for promising drugs
30 November 2017 - Scott Gottlieb speaks before House subcommittee on health. ...
Posted by Michael Wonder on 01 Dec 2017
FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
30 November 2017 - Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health ...
Posted by Michael Wonder on 01 Dec 2017
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
30 November 2017 - Agency encourages safe adoption and more widespread use of FDA-approved treatments to help combat opioid addiction. ...
Posted by Michael Wonder on 30 Nov 2017
Advancing medicinal nicotine replacement therapies as new drugs – a new step in FDA’s comprehensive approach to tobacco and nicotine
29 November 2017 - As the leading cause of preventable disease and death in the United States, tobacco causes more than ...
Posted by Michael Wonder on 30 Nov 2017
Adamis Pharmaceuticals submits prior approval supplement to FDA for the paediatric version of Symjepi
29 November 2017 - Adamis Pharmaceuticals today announced the submission of a prior approval supplement to the U.S. FDA for ...
Posted by Michael Wonder on 30 Nov 2017
FDA approves Ferring’s Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for colonoscopy prep
29 November 2017 - New ready-to-drink low-volume colonoscopy prep in a pre-mixed liquid solution. ...
Posted by Michael Wonder on 30 Nov 2017
Merck receives FDA approval for Isentress (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg
29 November 2017 - Only integrase inhibitor approved in the United States for treatment of HIV-1 in newborns from birth ...
Posted by Michael Wonder on 29 Nov 2017
Pharming submits supplemental biologics license application to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
27 November 2017 - Submission based on positive results from two clinical trials. ...
Posted by Michael Wonder on 29 Nov 2017
Trump backs bipartisan fixes to ObamaCare markets
28 November 2017 - President Trump at a closed-door meeting with GOP senators on Tuesday said he would support two ...
Posted by Michael Wonder on 29 Nov 2017
GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria
29 November 2017 - Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases. ...
Posted by Michael Wonder on 29 Nov 2017
U.S. FDA grants fast track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma
29 November 2017 - Phase 3 trial initiation planned for first quarter 2018. ...