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RSS FeedPosted by Michael Wonder on 21 Oct 2020
Zosano Pharma receives complete response letter from FDA for Qtrypta
21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...
Posted by Michael Wonder on 20 Oct 2020
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 ...
Posted by Michael Wonder on 20 Oct 2020
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 ...
Posted by Michael Wonder on 19 Oct 2020
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. ...
Posted by Michael Wonder on 19 Oct 2020
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. ...
Posted by Michael Wonder on 19 Oct 2020
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 ...
Posted by Michael Wonder on 18 Oct 2020
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. ...
Posted by Michael Wonder on 15 Oct 2020
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 ...
Posted by Michael Wonder on 15 Oct 2020
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 ...
Posted by Michael Wonder on 14 Oct 2020
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 ...
Posted by Michael Wonder on 14 Oct 2020
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. ...
Posted by Michael Wonder on 14 Oct 2020
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. ...
Posted by Michael Wonder on 13 Oct 2020
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. ...
Posted by Michael Wonder on 10 Oct 2020
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 ...
Posted by Michael Wonder on 09 Oct 2020
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 ...