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RSS FeedPosted by Michael Wonder on 15 Aug 2019
Harmony Biosciences announces FDA approval of Wakix (pitolisant), a first-in-class medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy
15 August 2019 - Wakix represents the first and only non-scheduled treatment approved for patients with narcolepsy in the U.S. ...
Posted by Michael Wonder on 14 Aug 2019
Syapse announces research collaboration with the FDA focused on the regulatory use of real-world evidence
14 August 2019 - Collaboration will advance the derivation of real-world oncology endpoints and provide insights into the use of real-world ...
Posted by Michael Wonder on 14 Aug 2019
FDA grants breakthrough therapy designation for trilaciclib based on myelopreservation data in small cell lung cancer patients
8 August 2019 - G1 Therapeutics today provided a corporate and financial update for the second quarter ended 30 June 2019. ...
Posted by Michael Wonder on 14 Aug 2019
Akari Therapeutics receives FDA fast track designation for nomacopan for paediatric haematopoietic stem cell transplant-related thrombotic microangiopathy
14 August 2019 - Proposed pivotal trial of nomacopan in paediatric patients with HSCT-TMA expected to start Q4 2019 in North ...
Posted by Michael Wonder on 14 Aug 2019
FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs
14 August 2019 - Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and ...
Posted by Michael Wonder on 14 Aug 2019
This drug will save children’s lives. It costs $2 million.
13 August 2019 - Safety, innovation and affordability need not be mutually exclusive goals for cutting-edge treatments. ...
Posted by Michael Wonder on 14 Aug 2019
Novartis violated FDA’s sacred principle: in God we trust, all others must bring data
14 August 2019 - A common saying at the Food and Drug Administration is: “In God we trust, all others ...
Posted by Michael Wonder on 14 Aug 2019
Calquence granted US breakthrough therapy designation for chronic lymphocytic leukaemia
14 August 2019 - Designation based on positive results from two Phase III trials. ...
Posted by Michael Wonder on 13 Aug 2019
DNA data shared in ways patients may find surprising
12 August 2019 - Hospitals engaged in private deals with drugmakers don’t always disclose the ways the data will be used. ...
Posted 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 ...