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RSS FeedPosted by Michael Wonder on 10 Nov 2018
Theravance Biopharma and Mylan receive FDA approval for Yuperli (revefenacin) in adults with chronic obstructive pulmonary disease
9 November 2018 - Yuperli (revefenacin) is the first and only once-daily, nebulised bronchodilator approved for the treatment of COPD in ...
Posted by Michael Wonder on 10 Nov 2018
FDA highlights record-breaking number of generic drug approvals in October
9 November 2018 - Today, the U.S. FDA is providing a summary of the generic drug approval actions for the ...
Posted by Michael Wonder on 10 Nov 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
10 November 2018 - Approval marks 14th indication for Keytruda. ...
Posted by Michael Wonder on 09 Nov 2018
Lilly snaps up regulatory 'fast pass' for bargain price
2 November 2018 - Priority review vouchers used to be highly sought: back in 2015, for example, AbbVie paid United ...
Posted by Michael Wonder on 09 Nov 2018
Coherus prices biosimilar to Amgen's Neulasta at 33 percent discount
9 November 2018 - Coherus BioSciences Inc said on Thursday it would price its biosimilar to Amgen Inc’s infection-fighting treatment, ...
Posted by Michael Wonder on 09 Nov 2018
Statement from FDA Commissioner on new efforts to strengthen FDA’s expanded access program
8 November 2018 - Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for ...
Posted by Michael Wonder on 07 Nov 2018
SpringWorks Therapeutics receives FDA fast track designation for nirogacestat for the treatment of adult patients with desmoid tumours
7 November 2018 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for nirogacestat, an investigational, ...
Posted by Michael Wonder on 07 Nov 2018
FDA releases real-world data collection app
7 November 2018 - FDA released on Tuesday an open source code app that can be used to collect real-world ...
Posted by Michael Wonder on 07 Nov 2018
Acacia Pharma resubmits Barhemsys new drug application
6 November 2018 - Acacia Pharma announces that it has resubmitted its new drug application for Barhemsys (amisulpride injection) to the ...
Posted by Michael Wonder on 07 Nov 2018
AbbVie announces Humira (adalimumab) global patent license with Momenta
6 November 2018 - AbbVie announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 07 Nov 2018
FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate to severe atopic dermatitis
6 November 2018 - Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 07 Nov 2018
U.S. FDA approves Empliciti (elotuzumab) plus pomalidomide and dexamethasone, a new immunotherapy combination for certain patients with relapsed or refractory multiple myeloma
6 November 2018 - In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone doubled median progression-free survival and overall ...
Posted by Michael Wonder on 06 Nov 2018
FDA approves novel single-vial formulation of Egrifta
5 November 2018 - Theratechnologies is pleased to announce that the FDA in the United States has approved the new ...
Posted by Michael Wonder on 06 Nov 2018
No matter what the FDA decides, new diabetes drugs will still require CV outcomes trials
6 November 2018 - At one time, Avandia (generic name: rosiglitazone) was a major diabetes drug for GSK with sales exceeding ...
Posted by Michael Wonder on 06 Nov 2018
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-101
5 November 2018 - Poseida Therapeutics today announced the U.S. FDA has granted a regenerative medicine advanced therapy designation to P-BCMA-101, ...