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RSS FeedPosted by Michael Wonder on 10 Aug 2016
Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting
10 August 2016 - Sustol is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea ...
Posted by Michael Wonder on 09 Aug 2016
Cancer-drug ads vs. cancer-drug reality
9 August 2016 - Two days into a long-dreamed-of family vacation to Italy in August 2013, my wife, Ronna, became nauseated, ...
Posted by Michael Wonder on 08 Aug 2016
New FDA documents reveal history of breakthrough therapy designation for Epclusa
5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 ...
Posted by Michael Wonder on 08 Aug 2016
Merck announces U.S. FDA filing acceptance of new drug application for MK-1293, an investigational follow-on biologic insulin glargine
5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review. ...
Posted by Michael Wonder on 06 Aug 2016
The FDA approves first generic version of widely used influenza drug Tamiflu
On August 3, 2016, the U.S. FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication ...
Posted by Michael Wonder on 06 Aug 2016
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
5 August 2016 - The U.S. FDA today issued draft updated recommendations to help manufacturers determine when they are required to ...
Posted by Michael Wonder on 04 Aug 2016
Drugmakers split on whether to include interchangeability statement in biosimilar labels
3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major ...
Posted by Michael Wonder on 04 Aug 2016
Microbion Corporation announces FDA has granted fast track designation to MBN-101 for the adjunctive treatment of moderate and severe diabetic foot ulcer infections
3 August 2016 - Microbion today announced that the U.S. FDA has granted MBN-101 fast track designation for adjunctive treatment of ...
Posted by Michael Wonder on 04 Aug 2016
More on FDA breakthrough therapies
4 August 2016 - The FDA has granted 148 breakthrough therapy designations as at 3 August 2016. Most of the ...
Posted by Michael Wonder on 03 Aug 2016
Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA breakthrough therapy designation as first-line treatment for HR+/HER2- advanced breast cancer
3 August 2016 - Designation underscores the continuing unmet need of the HR+/HER2- advanced breast cancer population and the potential of ...
Posted by Michael Wonder on 02 Aug 2016
Alcon achieves US approval for CyPass Micro-Stent, a micro invasive surgical device to treat glaucoma
2 August 2016 - US FDA grants approval for CyPass Micro-Stent for sale in the US, expanding Alcon's surgical presence to ...
Posted by Michael Wonder on 02 Aug 2016
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in children aged two and older
1 August 2016 - First and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. ...
Posted by Michael Wonder on 02 Aug 2016
FDA accepts BLA for BioMarin's cerliponase alfa for CLN2 disease, form of Batten disease
27 July 2016 - Potential first treatment for fatal, rare, brain disease in children. ...
Posted by Michael Wonder on 02 Aug 2016
Vaccinex receives FDA fast track designation for VX15 antibody for the treatment of Huntington’s disease
1 August 2016 - Vaccinex today announced that the U.S. FDA has granted fast track designation for VX15 as a potential ...
Posted by Michael Wonder on 01 Aug 2016
MEI Pharma's pracinostat receives breakthrough therapy designation from FDA for treatment in combination with azacitidine of patients with newly diagnosed acute myeloid leukaemia unfit for intensive chemotherapy
1 August 2016 - MEI Pharma announced today that the U.S. FDA has granted breakthrough therapy designation for the investigational drug ...