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 ...

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Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq

24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...

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Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute lymphoblastic leukaemia

24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...

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argenx announces FDA approval of Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy

21 June 2024 - Third approved indication for Vyvgart and Vyvgart Hytrulo franchise. ...

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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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Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

20 June 2024 - For a third time, Sarepta Therapeutics has convinced a top FDA official to overrule the prevailing ...

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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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Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older

21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...

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Takeda receives approval from European Commission for Fruzaqla in previously treated metastatic colorectal cancer

21 June 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...

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FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C mutated colorectal cancer

21 June 2024 - Today, the FDA granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics) plus cetuximab for adults with ...

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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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FDA expands approval of gene therapy for patients with Duchenne muscular systrophy

20 June 2024 - Today, the FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment ...

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FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis

20 June 2024 - FDA approval was supported by results from the two pivotal Phase 3 studies evaluating the efficacy ...

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Truqap plus Faslodex approved in the EU for patients with advanced oestrogen receptor positive breast cancer

20 June 2024 - Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or ...

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