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RSS FeedPosted by Michael Wonder on 12 Aug 2019
Canadians are hopping mad about Trump’s drug importation plan. Some of them are trying to stop it.
12 August 2019 - Canadians are furious about the Trump administration’s plan to import their prescription drugs. And some of ...
Posted by Michael Wonder on 12 Aug 2019
Daré Bioscience receives QIDP designation from the FDA for DARE-BV1 for the treatment of bacterial vaginosis
12 August 2019 - DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019. ...
Posted by Michael Wonder on 12 Aug 2019
Janssen announces U.S. FDA accelerated approval for Sirturo (bedaquiline) as part of combination therapy to treat adolescents with pulmonary multidrug-resistant tuberculosis
9 August 2019 - Label expansion marks important milestone in Johnson & Johnson’s paediatric research and development program for bedaquiline. ...
Posted by Michael Wonder on 12 Aug 2019
Avadel Pharmaceuticals receives new PDUFA date for AV001 of 15 December 2019
8 August 2019 - PDUFA action extended 3 months; launch remains on track for 1Q 2020. ...
Posted 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
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. ...