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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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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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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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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European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A

19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...

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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 approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults

17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...

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FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

17 June 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for ...

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FDA approves blinatumomab as consolidation for CD19 positive Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia

14 June 2024 - Today, the FDA approved blinatumomab (Blincyto, Amgen) for adult and paediatric patients one month and older ...

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FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

14 June 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with carboplatin plus paclitaxel followed by single-agent durvalumab for ...

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