Blog
RSS FeedPosted by Michael Wonder on 23 May 2017
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for treatment of recurrent or advanced gastric or gastro-oesophageal junction adenocarcinoma
23 May 2017 - Data supporting application to be presented at 2017 ASCO Annual Meeting. ...
Posted by Michael Wonder on 21 May 2017
ALPHAEON submits biologics license application for DWP-450 neuromodulator BLA submitted within three years of first patient enrolment
16 May 2017 - ALPHAEON today announced that its wholly-owned subsidiary Evolus, submitted a biologics license application for DWP-450, a Botulinum ...
Posted by Michael Wonder on 21 May 2017
Amgen submits biologics license application to the FDA for erenumab
18 May 2017 - Erenumab is an investigative treatment specifically designed to prevent migraine only molecule in late-stage development to ...
Posted by Michael Wonder on 19 May 2017
Spark Therapeutics completes rolling biologics license application submission to FDA for investigational gene therapy voretigene neparvovec
18 May 2017 - Voretigene neparvovec has the potential to be the first pharmacologic treatment for an inherited retinal disease ...
Posted by Michael Wonder on 19 May 2017
Sage Therapeutics receives fast track designation for SAGE-217 for the treatment of major depressive disorder
18 May 2017 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-217 for ...
Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response ...
Posted by Michael Wonder on 17 May 2017
Sangamo receives fast track designation from the FDA for SB-525 investigational haemophilia A gene therapy
16 May 2017 - Sangamo Therapeutics announced today that the U.S. FDA has granted fast track designation to SB-525, the Company's ...
Posted by Michael Wonder on 16 May 2017
Aerie Pharmaceuticals announces FDA acceptance of NDA submission for Rhopressa (netarsudil ophthalmic solution) 0.02%
15 May 2017 - PDUFA date set for 28 February 2018. ...
Posted by Michael Wonder on 16 May 2017
Ignyta granted breakthrough therapy designation for entrectinib by U.S. Food and Drug Administration
15 May 2017 - Ignyta today announced that the U.S. FDA has granted a breakthrough therapy designation to entrectinib for ...
Posted by Michael Wonder on 16 May 2017
Imara receives rare paediatric disease designation from FDA for lead product candidate IMR-687 for sickle cell disease
15 May 2017 - Imara announced today that the U.S. FDA has granted rare paediatric disease designation to IMR-687, the ...
Posted by Michael Wonder on 16 May 2017
Biohaven's trigriluzole receives fast track designation from U.S. FDA
15 May 2017 - Potential first-in-class therapy for spinocerebellar ataxia. ...
Posted by Michael Wonder on 12 May 2017
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the ...
Posted by Michael Wonder on 12 May 2017
FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure
11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...
Posted by Michael Wonder on 11 May 2017
GSK escapes Advair hit for now as second generic bid fails
11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United ...
Posted by Michael Wonder on 09 May 2017
TherapeuticsMD receives complete response letter from FDA for TX-004HR new drug application
8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC. ...