FDA approves expanded use of Cresemba (isavuconazonium sulphate) in children with invasive Aspergillosis and invasive Mucormycosis

8 December 2023 - Approval based on results of two paediatric studies in children aged 1 to 17. ...

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European Commission approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma

8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...

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FDA approves first gene therapies to treat patients with sickle cell disease

8 December 2023 - Today, the US FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies ...

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FDA Approves Bio-Thera Solutions' Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin

7 December 2023 - Avzivi is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA ...

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Health Canada approves FYB201/Ranopto (ranibizumab), a biosimilar to Lucentis

7 December 2023 - Formycon, Polpharma Biologics, Bioeq and Teva Canada jointly announce that Health Canada has granted the Notice ...

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Lilly announces Health Canada's authorisation of Verzenio (abemaciclib) label expansion

7 December 2023 - Verzenio's label expanded to include the full study population investigated in the Verzenio Phase 3 monarchE trial. ...

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Dupilumab for the treatment of patients with eosinophilic oesophagitis

7 December 2023 - NICE is unable to make a recommendation on the use of dupilumab (Dupixent) for the treatment of ...

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Bristol Myers Squibb's Abecma becomes first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan

6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new ...

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Secukinumab for the treatment of patients with moderate to severe hidradenitis suppurativa (final guidance)

6 December 2023 - NICE has published final evidence-based recommendations on the use of secukinumab (Cosentyx) for the treatment of ...

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Novartis receives FDA approval for Fabhalta (iptacopan), offering superior haemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

6 December 2023 - Approval based on APPLY-PNH trial in adults with PNH and anaemia despite prior anti-C5 treatment, and supported ...

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Litfulo receives Health Canada approval, becoming the first approved treatment for severe alopecia areata in Canada

4 December 2023 - A dual JAK3/TEC inhibitor, Litfulo (ritlecitinib) is approved for adults and adolescents over 12 years of ...

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UCB announces European Commission approval of Zilbrysq (zilucoplan) for the treatment of adults with generalised myasthenia gravis

4 December 2023 - Approval supported by pivotal Phase 3 RAISE study in generalised myasthenia gravis which demonstrated treatment with zilucoplan ...

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Health Canada grants market authorisation for Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 2 months and older

29 November 2023 - Vertex Pharmaceuticals today announced that Health Canada has granted market authorisation for the expanded use of ...

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FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma

1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...

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Idecabtagene vicleucel for the treatment of patients with relapsed and refractory multiple myeloma after 3 or more treatments

30 November 2023 - NICE is unable to make a recommendation on the use of idecabtagene vicleucel (Abecma) for the treatment ...

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