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RSS FeedPosted 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, ...
Posted by Michael Wonder on 06 Nov 2018
Seattle Genetics submits supplemental biologics license application for Adcetris (brentuximab vedotin) in front-line treatment of CD30 expressing peripheral T-cell lymphomas
5 November 2018 - Submission based on positive Phase 3 ECHELON-2 trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphoma. ...
Posted by Michael Wonder on 05 Nov 2018
Novartis says SMA gene therapy is cost-effective at $4-5 million per patient
5 November 2018 - Novartis, which is shifting into rare diseases, said on Monday it believes its new gene therapy ...
Posted by Michael Wonder on 05 Nov 2018
Aquestive Therapeutics announces U.S. FDA approval for Sympazan (clobazam) oral film
2 November 2018 - Sympazan is delivered via Aquestive's proprietary PharmFilm technology. ...
Posted by Michael Wonder on 04 Nov 2018
U.S. FDA approves Lorbrena (lorlatinib) for previously treated ALK-positive metastatic non-small cell lung cancer
2 November 2018 - Lorbrena addresses unmet needs for certain patients treated with prior ALK therapy. ...
Posted by Michael Wonder on 03 Nov 2018
AcelRx announces FDA approval of Dsuvia
2 November 2018 - First and only sufentanil sublingual tablet approved for acute pain in health care settings. ...