Blog
RSS FeedPosted 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 11 Jan 2018
ObamaCare repeal fades from GOP priorities list in new year
10 January 2018 - The chances of repealing ObamaCare this year are fading further, with top Republicans saying they hardly ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
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 09 Jan 2018
Eisai and Merck receive breakthrough therapy designation from U.S. FDA for Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma
9 January 2018 - Eisai and Merck announced today that they received breakthrough therapy designation from the U.S. FDA for Eisai’s ...
Posted by Michael Wonder on 09 Jan 2018
GBT receives FDA breakthrough therapy designation for voxelotor for treatment of sickle cell disease
9 January 2018 - Voxelotor is first investigational treatment for sickle cell disease to receive breakthrough therapy designation. ...
Posted by Michael Wonder on 09 Jan 2018
Reflections on a landmark year for medical product innovation and public health advances and looking ahead to policy in 2018
9 January 2018 - As we look ahead to 2018, I’d like to take a moment to reflect on an ...
Posted by Michael Wonder on 09 Jan 2018
FY 2017 Report from the Director
8 January 2018 - The Center for Biologics Evaluation and Research worked diligently during Fiscal Year 2017 to fulfil its ...
Posted by Michael Wonder on 09 Jan 2018
pSivida submits new drug application for Durasert three year treatment for posterior segment uveitis to the U.S. FDA
8 January 2018 - Proven Durasert technology has to date received FDA approval for three of the four sustained release drug ...
Posted by Michael Wonder on 08 Jan 2018
Plans to slash medical costs in America run into generic drug concerns
6 January 2018 - FDA generics push comes amid quality enforcement woes in India. ...
Posted by Michael Wonder on 08 Jan 2018
HHS nominee Azar needs to come clean on Obamacare, Medicare in Senate hearings
8 January 2018 - Alex Azar, who has been nominated to replace Tom Price as Health and Human Services Secretary is ...
Posted by Michael Wonder on 08 Jan 2018
Ionis' inotersen NDA accepted for priority review by the FDA
8 January 2018 - Ionis Pharmaceuticals announced today that its new drug application for inotersen has been accepted for priority review ...
Posted by Michael Wonder on 08 Jan 2018
AbbVie's upadacitinib granted breakthrough therapy designation from the U.S. FDA for atopic dermatitis
8 January 2018 - Phase 3 clinical program for upadacitinib in atopic dermatitis, the most common type of eczema, is planned ...
Posted by Michael Wonder on 07 Jan 2018
Medical research? Congress cheers. Medical care? Congress brawls.
6 January 2018 - They cannot agree on subsidies for low-income people under the Affordable Care Act or even how ...