Blog
RSS FeedPosted by Michael Wonder on 11 Aug 2019
The FDA’s digital health chief on how to regulate futuristic AI products
9 August 2019 - The FDA has allowed medical devices that rely on artificial intelligence algorithms onto the market, but ...
Posted by Michael Wonder on 11 Aug 2019
US patients struggle to obtain Eli Lilly’s half-price insulin
11 August 2019 - Cheaper option was unveiled shortly before company was grilled by Congress about soaring prices. ...
Posted by Michael Wonder on 11 Aug 2019
Patient groups push back against Gilead's pricey HIV prevention treatment
7 August 2019 - Gilead Sciences hopes to soon introduce a pricey new pill to prevent HIV in people at risk ...
Posted by Michael Wonder on 11 Aug 2019
The evolution of real world studies
9 August 2019 - The use of real-world evidence is evolving quickly. ...
Posted by Michael Wonder on 10 Aug 2019
Kala Pharmaceuticals receives FDA complete response letter for KPI-121 0.25% NDA and plans to respond with data from STRIDE 3 trial
8 August 2019 - Targeting top-line data from STRIDE 3 by the end of 2019. ...
Posted 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
Molecular Partners’ strategic partner Allergan announced today that EMA has validated the marketing authorisation application for abicipar
6 August 2019 - Molecular Partners today announced that the EMA has validated the marketing authorisation application of its strategic partner ...
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 ...