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RSS FeedPosted by Michael Wonder on 08 Dec 2023
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. ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 08 Dec 2023
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. ...
Posted by Michael Wonder on 07 Dec 2023
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 ...
Posted by Michael Wonder on 07 Dec 2023
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 ...
Posted by Michael Wonder on 06 Dec 2023
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 ...
Posted by Michael Wonder on 06 Dec 2023
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 ...
Posted by Michael Wonder on 05 Dec 2023
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 ...
Posted by Michael Wonder on 04 Dec 2023
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 ...
Posted by Michael Wonder on 02 Dec 2023
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 ...
Posted by Michael Wonder on 01 Dec 2023
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 ...
Posted by Michael Wonder on 30 Nov 2023
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 ...