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 ...

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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. ...

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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. ...

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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 ...

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KalVista submits new drug application to FDA for sebetralstat as first oral on-demand treatment for hereditary angioedema

18 June 2024 - KalVista Pharmaceuticals today announced the submission of a new drug application for US FDA review of ...

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Subcutaneous amivantamab biologics license application submitted to US FDA for patients with EGFR mutated non-small-cell lung cancer

17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration ...

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Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate

17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...

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Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine

14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...

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Receipt of complete response letter from US FDA for ND0612

11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...

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Tagrisso granted priority review in the US for patients with unresectable, stage III EGFR mutated lung cancer

10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...

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FDA accepts filing of Leqembi (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease

8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for ...

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Moderna files FDA application for the JN.1 targeting COVID-19 vaccine

7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...

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FDA accepts for review treosulfan NDA resubmission

6 June 2024 - Today, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialisation rights to treosulfan, that the ...

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Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix

4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...

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Telix completes TLX250-CDx (Zircaix) BLA submission for kidney cancer imaging

3 June 2024 - Telix today announces that it has completed the submission of a biologics license application to the ...

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