Blog
RSS FeedPosted by Michael Wonder on 19 Jan 2018
Avion Pharmaceuticals announces approval of first NDA in the oral contraceptive category
18 January 2018 - Avion Pharmaceuticals received approval of its new drug application for the oral contraceptive Balcoltra (levonorgestrel and ...
Posted by Michael Wonder on 18 Jan 2018
FDA approves addition of overall survival data to Kyprolis (carfilzomib) label
17 January 2018 - Phase 3 data showed Kyprolis and dexamethasone reduced the risk of death by 21% versus Velcade ...
Posted by Michael Wonder on 17 Jan 2018
An open letter to Dr. Scott Gottlieb on FDA transparency
17 January 2018 - Dear Dr. Scott Gottlieb: ...
Posted by Michael Wonder on 17 Jan 2018
Gottlieb changes course on FDA publication of rejection letters
16 January 2018 - Before Scott Gottlieb was in charge of the FDA, he called on the agency to publicly ...
Posted by Michael Wonder on 16 Jan 2018
Teva announces U.S. FDA approval of Trisenox (arsenic trioxide) injection for first-line treatment of acute promyelocytic leukaemia
15 January 2018 - Teva Pharmaceutical Industries announced that the U.S. FDA has approved the use of Trisenox (arsenic trioxide) injection ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 13 Jan 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
12 January 2018 - The U.S. FDA today expanded the approved use of Lynparza (olaparib) to include the treatment of patients ...
Posted by Michael Wonder on 11 Jan 2018
Many “firsts” for CDER’s 2017 drug approvals reflect innovation and enhanced patient care
10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in ...
Posted by Michael Wonder on 10 Jan 2018
The health 202: This year's top 10 new drugs
9 January 2018 - Yes, overall spending on prescription drugs has slowed recently, but expect Democrats to pummel Alex Azar ...
Posted by Michael Wonder on 06 Jan 2018
FDA approves Xgeva (denosumab) for the prevention of skeletal-related events in patients with multiple myeloma
5 January 2018 - Approval based on safety and efficacy data from the largest international multiple myeloma clinical trial ever conducted. ...
Posted by Michael Wonder on 04 Jan 2018
Landmark schizophrenia data that bring hope in breaking the cycle of hospitalisation and incarceration receive FDA approval for inclusion in Invega Sustenna (paliperidone palmitate) label
3 January 2017 - Invega Sustenna is the first and only antipsychotic to demonstrate superior effectiveness in delaying time to ...
Posted by Michael Wonder on 29 Dec 2017
New drug approvals for FDA: 2017 hits 21 year high
21 December 2017 - The number of new molecular entities approved by the US FDA in 2017 (46 so far, ...
Posted by Michael Wonder on 28 Dec 2017
Horizon Pharma announces FDA approval to expand the indication for Procysbi (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis
27 December 2017 - Horizon Pharma today announced the U.S. FDA has approved an expansion to the indication for Procysbi (cysteamine ...
Posted by Michael Wonder on 26 Dec 2017
Six health stories to watch in 2018
24 December 2017 - A new year could bring new treatments for migraines and breast cancer, greater access to a powerful ...
Posted by Michael Wonder on 23 Dec 2017
Many FDA approved cancer drugs might lack clinical benefit
21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...