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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FDA approves Adbry (tralokinumab-ldrm) auto-injector for the treatment of adults with moderate to severe atopic dermatitis

13 June 2024 - Single-dose auto-injector will provide adult patients in the US with an alternative method of administration for Adbry, ...

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FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours

13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...

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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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Baricitinib for the treatment of patients with juvenile idiopathic arthritis

13 June 2024 - NICE is unable to make a recommendation on the use in the NHS of baricitinib (Olumiant) for ...

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FDA approves selpercatinib for RET fusion positive thyroid cancer

12 June 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...

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Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus

12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...

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Pembrolizumab in combination with trastuzumab and chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastro-oesophageal junction adenocarcinoma (final guidance)

12 June 2024 - NICE has published evidence-based recommendations on the use of pembrolizumab (Keytruda) in combination with trastuzumab and ...

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Voxelotor for the treatment of patients with haemolytic anaemia caused by sickle cell disease

12 June 2024 - NICE has published final evidence-based recommendations on the use of voxelotor (Oxbryta) for the treatment of ...

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Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis

11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...

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