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RSS FeedPosted by Michael Wonder on 06 Aug 2019
Novartis stands behind Zolgensma (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
6 August 2019 - Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for ...
Posted by Michael Wonder on 06 Aug 2019
Novartis hid manipulated data while seeking approval for $2.1 million treatment
6 August 2019 - The failure to report the issue has not put patients at risk, the F.D.A. said, but the ...
Posted by Michael Wonder on 06 Aug 2019
Rockwell Medical announces acceptance by FDA of new drug application for I.V. Triferic
6 August 2019 - FDA establishes PDUFA date of 28 March 2020 for I.V. Triferic ...
Posted by Michael Wonder on 06 Aug 2019
Statement on data accuracy issues with recently approved gene therapy
6 August 2019 - As a public health agency, we believe that it is critical to facilitate the development of ...
Posted by Michael Wonder on 06 Aug 2019
Bracco Diagnostics receives U.S. FDA approval for Varibar Thin Liquid (barium sulphate) for oral suspension
5 August 2019 - Bracco Diagnostics today announced the FDA approval for Varibar Thin Liquid (barium sulphate) for oral suspension which ...
Posted by Michael Wonder on 06 Aug 2019
Provention Bio announces breakthrough therapy designation for teplizumab for the prevention or delay of clinical type 1 diabetes in at-risk individuals
5 August 2019 - Provention Bio today announced that the U.S. FDA has granted breakthrough therapy designation to teplizumab (PRV-031) ...
Posted by Michael Wonder on 05 Aug 2019
Foamix submits new drug application to U.S. FDA for FMX103 for the treatment of moderate-to-severe papulopustular rosacea
5 August 2019 - Foamix Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 05 Aug 2019
Alnylam announces U.S. FDA granted priority review of the givosiran new drug application for the treatment of acute hepatic porphyria
5 August 2019 - PDUFA date set for 4 February 2020. ...
Posted by Michael Wonder on 05 Aug 2019
AbbVie submits new drug application to US FDA for investigational elagolix for management of heavy menstrual bleeding associated with uterine fibroids in women
5 August 2019 - New drug application is supported by data from pivotal Phase 3 studies of nearly 800 patients. ...
Posted by Michael Wonder on 05 Aug 2019
FDA issues draft guidance regarding clinical trial design for newborns
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...
Posted by Michael Wonder on 04 Aug 2019
Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’
1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...
Posted by Michael Wonder on 03 Aug 2019
FDA approves first therapy for rare joint tumour
2 August 2019 - Today, the U.S. FDA granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held ...
Posted by Michael Wonder on 02 Aug 2019
Toppling the ethical balance — health care refusal and the Trump administration
31 July 2019 - For nearly 50 years, U.S. federal law has permitted medical professionals and religious institutions to refuse, ...
Posted by Michael Wonder on 01 Aug 2019
Eton Pharmaceuticals announces FDA acceptance of new drug application for ET-105
1 August 2019 - ET-105 assigned Prescription Drug User Fee Act target action date of 17 March 2020. ...