Blog
RSS FeedPosted by Michael Wonder on 04 Jul 2019
Karyopharm Therapeutics prices blood cancer treatment after FDA approval
4 July 2019 - Karyopharm Therapeutics has set a list-price for its blood cancer treatment Xpovio at $22,000 per month, ...
Posted by Michael Wonder on 04 Jul 2019
RedHill Biopharma announces FDA acceptance of new drug application for Talicia
3 July 2019 - U.S. FDA accepts NDA for priority review. ...
Posted by Michael Wonder on 03 Jul 2019
FDA accepts new drug application for INSYS Therapeutics’ naloxone nasal spray for the emergency treatment of known or suspected opioid overdose
3 July 2019 - INSYS Therapeutics announced today that its new drug application to the U.S. FDA for its investigational, proprietary ...
Posted 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 ...