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RSS FeedPosted by Michael Wonder on 24 Aug 2016
Amgen provides update on status of Parsabiv (etelcalcetide) new drug application submitted to the U.S. FDA
24 August 2016 - Amgen today announced that the U.S. FDA has issued a complete response letter for the new drug ...
Posted by Michael Wonder on 23 Aug 2016
Stemline Therapeutics receives breakthrough therapy designation from U.S. FDA for SL-401
23 August 2016 - Stemline Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to SL-401. ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 22 Aug 2016
Lilly and AstraZeneca receive FDA fast track designation for AZD3293, an investigational treatment for early Alzheimer's disease
22 August 2016 - AZD3293 is an oral potent small molecule BACE inhibitor in phase 3 development. ...
Posted by Michael Wonder on 18 Aug 2016
Portola Pharmaceuticals receives complete response letter from FDA for biologics license application for AndexXa (andexanet alfa)
17 August 2016 - Portola Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 17 Aug 2016
Esketamine receives breakthrough therapy designation from U.S. Food and Drug Administration for major depressive disorder with imminent risk for suicide
16 August 2016 - FDA action marks second breakthrough therapy designation for intranasal esketamine, highlighting its potential as treatment for patients ...
Posted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...
Posted by Michael Wonder on 11 Aug 2016
Heart of bureaucratic darkness
9 August 2016 - Why won’t the FDA make a decision on a muscular dystrophy drug? ...
Posted by Michael Wonder on 11 Aug 2016
The future of cardiovascular medicine from the regulatory perspective
10 August 2016 - For many years, the American public and the entire world have benefited from the U.S. FDAs’ regulatory ...
Posted 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 ...