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RSS FeedPosted by Michael Wonder on 05 Mar 2021
Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia
3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 04 Mar 2021
Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
Posted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 03 Mar 2021
Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
Posted by Michael Wonder on 03 Mar 2021
On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
Posted by Michael Wonder on 03 Mar 2021
Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...
Posted by Michael Wonder on 02 Mar 2021
Eyenovia announces FDA acceptance of the MydCombi new drug application
2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...
Posted by Michael Wonder on 02 Mar 2021
GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
Posted by Michael Wonder on 01 Mar 2021
Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma
1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 01 Mar 2021
U.S. FDA accepts Merck’s gefapixant new drug application for review
1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in ...
Posted by Michael Wonder on 01 Mar 2021
Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 01 Mar 2021
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...