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RSS FeedPosted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
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 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 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 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 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted by Michael Wonder on 23 Sep 2020
UCB achieves important regulatory milestone for bimekizumab
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...
Posted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 27 Aug 2020
The EU Commission grants conditional approval for Idefirix (imlifidase) in highly sensitised kidney transplant patients in the European Union
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...