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RSS FeedPosted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 22 Feb 2023
Pfizer’s elranatamab receives FDA and EMA filing acceptance
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma. ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile ...
Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU. ...