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RSS FeedPosted by Michael Wonder on 16 Aug 2019
FDA approves treatment for patients with rare bone marrow disorder
16 August 2019 - Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with ...
Posted by Michael Wonder on 16 Aug 2019
AbbVie receives FDA approval of Rinvoq (upadacitinib), an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis
16 August 2019 - Approval supported by efficacy and safety data from one of the largest registrational Phase 3 programs in ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves Genentech’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours
15 August 2019 - First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer ...
Posted by Michael Wonder on 15 Aug 2019
The lengths Americans go to for cheap medicine
15 August 2019 - With drug prices soaring in the US, people are travelling to Canada to buy life-saving medication. ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
15 August 2019 - FDA also approves drug for second indication in a type of lung cancer. ...
Posted 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. ...