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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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, ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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