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RSS FeedPosted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 29 Jun 2024
Soleno Therapeutics announces submission of new drug application to the US FDA for diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for ...
Posted by Michael Wonder on 29 Jun 2024
Mirum submits new drug application to FDA for chenodiol for the treatment of CTX
28 June 2024 - Mirum Pharmaceuticals today announced the submission of a new drug application for chenodiol for the treatment of ...
Posted by Michael Wonder on 29 Jun 2024
Iovance Biotherapeutics submits marketing authorisation application to European Medicines Agency for lifileucel in advanced melanoma
28 June 2024 - First of multiple planned global submissions for lifileucel in 2024 and 2025. ...
Posted by Michael Wonder on 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
Posted by Michael Wonder on 27 Jun 2024
Ionis announces olezarsen FCS new drug application accepted for priority review
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
Posted by Michael Wonder on 26 Jun 2024
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025. ...
Posted by Michael Wonder on 26 Jun 2024
Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older
25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...
Posted by Michael Wonder on 25 Jun 2024
Jemperli (dostarlimab) plus chemotherapy application accepted for review by the EMA to expand use to all patients with primary advanced or recurrent endometrial cancer
24 June 2024 - Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 ...
Posted by Michael Wonder on 25 Jun 2024
Novavax submits application to EMA for updated protein-based 2024-2025 formula COVID-19 vaccine
24 June 2024 - Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 ...
Posted by Michael Wonder on 23 Jun 2024
Lexicon Pharmaceuticals resubmits sotagliflozin NDA for type 1 diabetes
21 June 2024 - Lexicon seeks approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with ...
Posted by Michael Wonder on 23 Jun 2024
Neurotech Pharmaceuticals receives priority review of biologics license application for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia type 2
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
Posted by Michael Wonder on 21 Jun 2024
Johnson & Johnson submits application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of moderately to severely active Crohn's disease
20 June 2024 - Submission is supported by 48 week results from the Phase 3 GALAXI and GRAVITI programs. ...
Posted by Michael Wonder on 21 Jun 2024
European Medicines Agency validates Bristol Myers Squibb’s application for subcutaneous nivolumab
21 June 2024 - Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation ...