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RSS FeedPosted by Michael Wonder on 13 Aug 2019
FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database
13 August 2019 - Today, the U.S. FDA announced that it will inactivate listing records in its database that have not ...
Posted by Michael Wonder on 13 Aug 2019
Why America’s biggest charities are owned by pharmaceutical companies
13 August 2019 - Their generosity helps their bottom line. ...
Posted by Michael Wonder on 13 Aug 2019
Windtree announces FDA fast track designation for istaroxime
13 August 2019 - Fast track designation highlights the potential for istaroxime to address unmet medical needs of patients hospitalised with ...
Posted by Michael Wonder on 13 Aug 2019
Memo to the Novartis CEO: when in doubt, give the FDA a heads-up
13 August 2019 - For someone who has made a point of trying to steer Novartis away from scandal, Vas ...
Posted by Michael Wonder on 13 Aug 2019
FDA approves Eylea (aflibercept) injection pre-filled syringe
13 August 2019 - Eylea is the only anti-VEGF approved to treat four retinal conditions with a single dose strength pre-filled ...
Posted by Michael Wonder on 12 Aug 2019
Democratic senators urge FDA to take action against drug company that hid faulty data
9 August 2019 - A group of Democratic senators is urging the Food and Drug Administration (FDA) to take action ...
Posted 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. ...