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RSS FeedPosted by Michael Wonder on 16 Nov 2020
Lupin announces FDA filing acceptance of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
16 November 2020 - Lupin Pharmaceuticals announced today that the U.S. FDA has accepted their supplemental new drug application for ...
Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 ...
Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 12 Nov 2020
BioXcel Therapeutics announces completion of pre-NDA meeting with FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders
11 November 2020 - Initiated rolling submission of new drug application with U.S. FDA. ...
Posted by Michael Wonder on 10 Nov 2020
Supernus provides regulatory updates for SPN-812 and SPN-830
9 November 2020 - The U.S. FDA has issued a complete response letter regarding the new drug application for SPN-812 ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 09 Nov 2020
Impel Neuropharma announces FDA submission of new drug application for INP104 for the acute treatment of migraine
9 November 2020 - The INP104 new drug application is supported by results from the Phase 3 STOP 301 trial. ...
Posted by Michael Wonder on 09 Nov 2020
Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
Posted by Michael Wonder on 03 Nov 2020
Food and Drug Administration accepts BioMarin's new drug application for vosoritide to treat children with achondroplasia
2 November 2020 - If approved, first therapy in U.S. for the treatment of achondroplasia. ...
Posted by Michael Wonder on 03 Nov 2020
Provention Bio completes rolling submission of the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
2 November 2020 - Submission of chemistry, manufacturing and controls and administrative information modules represent completion of the Company's submission for ...
Posted by Michael Wonder on 02 Nov 2020
Janssen submits paliperidone palmitate 6 month supplemental new drug application to U.S. FDA for treatment of schizophrenia in adults
2 November 2020 - If approved, paliperidone palmitate 6 month will be the first and only long-acting injectable schizophrenia treatment with a ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...
Posted by Michael Wonder on 27 Oct 2020
FDA grants priority review and EMA accepts regulatory submission for Pfizer's abrocitinib, an oral once daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as ...
Posted by Michael Wonder on 26 Oct 2020
Santen announces U.S. FDA filing acceptance of new drug application for cyclosporin 0.1% topical ophthalmic emulsion for the treatment of severe vernal keratoconjunctivitis in patients ages 4-18
26 October 2020 - Santen today announced that the U.S. FDA has accepted the new drug application for cyclosporin 0.1% topical ...