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RSS FeedPosted by Michael Wonder on 26 Oct 2020
Janssen submits application to U.S. FDA for new indication to expand use of Xarelto (rivaroxaban) in patients with peripheral artery disease
26 October 2020 - Application seeks approval of Xarelto plus aspirin to reduce the risk of major thrombotic vascular events in ...
Posted by Michael Wonder on 26 Oct 2020
Spectrum Pharmaceuticals announces that the FDA is deferring its action on the BLA for Rolontis (eflapegrastim)
26 October 2020 - Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel ...
Posted 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 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
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 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 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 ...
Posted by Michael Wonder on 09 Oct 2020
Eton Pharmaceuticals announces acceptance for filing of new drug application for orphan drug dehydrated alcohol injection
8 October 2020 - Application assigned a PDUFA date of 27 May 2021. ...
Posted by Michael Wonder on 08 Oct 2020
Regeneron asks FDA for emergency approval for drug that Trump claimed cured him
7 October 2020 - The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible ...
Posted by Michael Wonder on 08 Oct 2020
NDA submission for Polarean’s hyperpolarised 129 Xenon gas drug-device diagnostic for lung imaging
7 October 2020 - Polarean Imaging announces its submission of a new drug application and request for priority review to the ...