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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The opaque industry secretly inflating prices for prescription drugs

21 June 2024 - Pharmacy benefit managers are driving up drug costs for millions of people, employers and Government. ...

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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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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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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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What good are whizzy new drugs if the world can’t afford them?

14 June 2024 - Bringing gene therapies and obesity drugs to the masses will require financial innovation too, says Steven Pearson. ...

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Aurion Biotech receives breakthrough therapy designation and regenerative medicine advanced therapy designation for its drug candidate AURN001

19 June 2024 - First allogeneic cell therapy to receive both FDA designations for the treatment of corneal oedema secondary to ...

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How AI is revolutionising drug development

17 June 2024 - In high-tech labs, workers are generating data to train AI algorithms to design better medicine, faster. But ...

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US FDA approves Skyrizi (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie's portfolio across inflammatory bowel disease

18 June 2024 - Approval supported by two Phase 3 clinical trials that evaluated Skyrizi for the treatment of moderate to ...

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Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies

17 June 2024 - Launching Yimmugo in the US will over time significantly add to Grifols Group sales and underpins ...

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US FDA rare paediatric disease designation granted to RC220 bisantrene for the treatment of paediatric AML

18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...

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