Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2019
FDA approves new treatment for refractory multiple myeloma
3 July 2019 - Today, the U.S. FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone ...
Posted by Michael Wonder on 03 Jul 2019
Some insurers are pushing back on the high price for a Novartis gene therapy
3 July 2019 - Barely a month after Novartis won U.S. regulatory approval for its gene therapy — the most ...
Posted by Michael Wonder on 03 Jul 2019
Validation of patient reported outcomes: a low bar
3 July 2019 - It used to be that if we wanted to assess a patient’s back pain, we would evaluate ...
Posted by Michael Wonder on 02 Jul 2019
Innovation prizes to support cell and gene therapy
2 July 2019 - Personalised cell and gene therapy represent a fundamental therapeutic revolution. ...
Posted by Michael Wonder on 02 Jul 2019
Statement on steps to make health care professional and patient labelling information for prescription medications consistent and clear
1 July 2019 - The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate ...
Posted by Michael Wonder on 02 Jul 2019
FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV
1 July 2019 - The U.S. FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate) in 2004 for the treatment of HIV-1 infection in ...
Posted by Michael Wonder on 01 Jul 2019
Puma Biotechnology submits a supplemental new drug application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer
1 July 2019 - Puma Biotechnology has submitted a supplemental new drug application to the U.S. FDA for neratinib in ...
Posted by Michael Wonder on 01 Jul 2019
Retrophin announces FDA approval of Thiola EC (tiopronin) 100 mg and 300 mg tablets for the treatment of cystinuria
28 June 2019 - Enteric-coated formulation offers flexible dosing options, including administration with or without food. ...
Posted by Michael Wonder on 29 Jun 2019
Pfizer receives U.S. FDA approval for its first biosimilar, Zirabev (bevacizumab-bvzr)
28 June 2019 - Pfizer today announced the U.S. FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the ...
Posted by Michael Wonder on 28 Jun 2019
Durect announces submission to FDA of a full response to the Posimir complete response letter
27 June 2019 - Durect Corporation today announced it has submitted a full response to the complete response letter it previously ...
Posted by Michael Wonder on 28 Jun 2019
Arrowhead Pharmaceuticals receives fast track designation for ARO-AAT for treatment of alfa-1 liver disease
27 June 2019 - Arrowhead Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ARO-AAT, the company’s ...
Posted by Michael Wonder on 28 Jun 2019
Janssen announces U.S. FDA approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant ineligible
27 June 2019 - Combination regimen reduced the risk of disease progression or death by 44% in newly diagnosed patients who ...
Posted by Michael Wonder on 27 Jun 2019
Dova Pharmaceuticals announces FDA approval of supplemental new drug application for Doptelet (avatrombopag) for treatment of chronic immune thrombocytopenia
27 June 2019 - Company strengthens thrombocytopenia portfolio with ITP approval and expanded partnership with Salix for chronic liver disease indication. ...
Posted by Michael Wonder on 27 Jun 2019
Pfizer names former FDA Chief Gottlieb to Board of Directors
28 June 2019 - Scott Gottlieb, who stepped down as the chief of the U.S. FDA earlier this year, is ...
Posted by Michael Wonder on 27 Jun 2019
FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare auto-immune disease of the central nervous system
27 June 2019 - The U.S. FDA today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica ...