Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of ...
Posted by Michael Wonder on 03 Apr 2018
Alkermes receives refusal to file letter from FDA for ALKS 5461
2 April 2018 - Alkermes today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 30 Mar 2018
Sunovion submits new drug application to the FDA for apomorphine sublingual film (APL-130277) for the treatment of off episodes associated with Parkinson's disease
30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy ...
Posted by Michael Wonder on 30 Mar 2018
Insmed submits new drug application to FDA for ALIS in NTM lung disease caused by MAC
29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product. ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 27 Mar 2018
Palatin Technologies announces submission of bremelanotide NDA to FDA for treatment of hypoactive sexual desire disorder in premenopausal women
26 March 2018 - Palatin Technologies announced today that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a ...
Posted by Michael Wonder on 27 Mar 2018
Bayer announces completion of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancer
26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new ...
Posted by Michael Wonder on 19 Mar 2018
pSivida announces FDA acceptance for filing of new drug application for Durasert three-year treatment for posterior segment uveitis
19 March 2018 - pSivida today announced that its new drug application for Durasert three-year treatment for posterior segment uveitis ...
Posted by Michael Wonder on 16 Mar 2018
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for previously treated advanced hepatocellular carcinoma
15 March 2018 - In the pivotal phase 3 CELESTIAL trial, Cabometyx provided a statistically significant and clinically meaningful improvement ...
Posted by Michael Wonder on 15 Mar 2018
FDA accepts for filing supplemental biologics license application for Xeomin (incobotulinumtoxinA) in adult patients with sialorrhoea
14 March 2018 - Merz North America announced today that the U.S. FDA has accepted for filing a supplemental biologics license ...
Posted by Michael Wonder on 14 Mar 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytuda (pembrolizumab) for treatment of advanced cervical cancer
13 March 2018 - First filing acceptance for an anti-PD-1 therapy in cervical cancer. ...
Posted by Michael Wonder on 09 Mar 2018
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act date for TX-001HR
8 March 2018 - No filing review issues identified. ...
Posted by Michael Wonder on 09 Mar 2018
Veloxis files with FDA for the de novo indication for Envarsus XR
7 March 2018 - Veloxis Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. ...
Posted by Michael Wonder on 06 Mar 2018
Jazz Pharmaceuticals announces FDA acceptance of NDA for solriamfetol (JZP-110) for excessive sleepiness associated with narcolepsy or obstructive sleep apnea
2 March 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with standard review the company's ...
Posted by Michael Wonder on 05 Mar 2018
U.S. FDA accepts new drug application for prucalopride (SHP555) for chronic idiopathic constipation
5 March 2018 - Submission includes real-world evidence from an observational, pharmacoepidemiology cardiovascular safety study. ...