Blog
RSS FeedPosted by Michael Wonder on 10 Aug 2019
Presidential candidates aren’t talking about drug shortages. They should be.
9 August 2019 - In the conclusion of her recently published book, “Bottle of Lies,” Katherine Eban briefly notes that ...
Posted by Michael Wonder on 08 Aug 2019
DBV Technologies submits biologics license application to U.S. FDA for Viaskin Peanut for the treatment of peanut allergy
7 August 2019 - DBV Technologies today announced the submission of its biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 07 Aug 2019
Ortho Dermatologics announces U.S. FDA filing acceptance for IDP-123 treatment for acne vulgaris in lotion form
7 August 2019 - Bausch Health and its dermatology business, Ortho Dermatologics, today announced that the U.S. FDA has accepted the ...
Posted by Michael Wonder on 07 Aug 2019
FDA should take additional steps to address factors that may affect approval rates in the first review cycle
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
Posted by Michael Wonder on 07 Aug 2019
AMAG's female libido injectable therapy to sell at $899
7 August 2019 - AMAG Pharmaceuticals Inc’s treatment to boost sexual desire in premenopausal women will be offered at $899 ...
Posted by Michael Wonder on 07 Aug 2019
Blueprint Medicines announces FDA acceptance of new drug application for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
7 August 2019 - FDA grants priority review and sets PDUFA date for 14 February 2020. ...
Posted 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. ...