Zosano Pharma receives complete response letter from FDA for Qtrypta

21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...

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Tagrisso granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

20 October 2020 - Unprecedented results show treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in ...

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Swissmedic fast-tracks second anti-viral vaccine

19 October 2020 - Swissmedic said the United States pharmaceutical company Pfizer submitted an application for the authorisation of a ...

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U.S. Food and Drug Administration accepts for priority review applications for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma

19 October 2020 - U.S. Food and Drug Administration assigned a target action date of 20 February 2021. ...

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Agios announces withdrawal of European marketing authorisation application for Tibsovo as a treatment for relapsed or refractory IDH1 mutant acute myeloid leukaemia

16 October 2020 - Agios continues to advance two Phase 3 combination trials of Tibsovo in newly diagnosed AML patients. ...

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AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) in atopic dermatitis

19 October 2020 - In three pivotal Phase 3 studies, Rinvoq met co-primary and all secondary endpoints in adult and adolescent ...

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Pfizer to seek FDA approval for COVID-19 vaccine in November

16 October 2020 - US group and German partner BioNTech prepare to submit trial results next month. ...

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Scynexis announces submission of new drug application to the U.S. FDA for oral ibrexafungerp for the treatment of vaginal yeast infection

15 October 2020 - NDA submission is supported by positive data from two Phase 3 studies (VANISH Program) in women with ...

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EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine

15 October 2020 - The EMA has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the ...

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U.S. FDA accepts Biohaven's supplemental new drug application of Nurtec ODT for the preventive treatment of migraine

14 October 2020 - Acceptance marks critical milestone in Biohaven's efforts to develop Nurtec ODT as a unique dual therapy for ...

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Bayer submits supplemental new drug application to the FDA for intrauterine device Mirena (levonorgestrel releasing intrauterine system) 52 mg

14 October 2020 - Application seeks to extend duration of use up to seven years for Mirena. ...

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CTI BioPharma initiates rolling submission of new drug application for pacritinib in myelofibrosis patients with severe thrombocytopenia

13 October 2020 - Completion of submission expected in first quarter 2021. ...

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Moderna announces initiation of rolling submission to Health Canada for mRNA vaccine against COVID-19 (mRNA-1273)

13 October 2020 - Confirmation underscores Moderna’s commitment to make its vaccine available in Canada. ...

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Pfizer Canada and BioNTech initiate rolling submission to Health Canada for SARS-CoV-2 vaccine candidate BNT162b2

9 October 2020 - Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ...

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NDA filing for Luye Pharma’s anti-depressant drug LY03005 accepted by the U.S. FDA

4 March 2020 - Luye Pharma Group has announced that the U.S. FDA has reviewed and accepted the filing of ...

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