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Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria – Sanofi + Regeneron

Written by | 14 May 2025

The FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1… read more.

NICE (UK) terminated appraisal for Onivyde (pegylated liposomal irinotecan) in combination for untreated metastatic pancreatic cancer – Servier

Written by | 13 May 2025

NICE (UK) is unable to make a recommendation about the use in the NHS of pegylated liposomal irinotecan plus oxaliplatin, 5-fluorouracil and leucovorin for untreated metastatic pancreatic cancer… read more.

FDA approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma – BMS

Written by | 12 May 2025

Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the… read more.

Bimzelx (bimekizumab) two-year data at EHSF 2025 demonstrate sustained disease control in hidradenitis suppurativa – UCB

Written by | 11 May 2025

UCB announced long-term data from the BE HEARD trials for Bimzelx (bimekizumab) in moderate to severe hidradenitis suppurativa (HS). These two-year data, building on the established efficacy profile… read more.

Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma – GSK

Written by | 10 May 2025

GSK plc announced the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep is approved for the treatment of adults with… read more.

Tremfya (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease – J&J

Written by | 9 May 2025

J&J announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for Tremfya (guselkumab) to… read more.

Roche provides update on phase III Ocrevus (ocrelizumab) high dose study in people with relapsing multiple sclerosis

Written by | 8 May 2025

Roche announced that the Phase III MUSETTE trial comparing a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion to the currently approved Ocrevus IV 600 mg dose in… read more.

Teva and Samsung Bioepis announce biosimilar Epysqli (eculizumab-aagh) injection now available in the United States

Written by | 7 May 2025

Teva Pharmaceutical Industries Ltd. , and Samsung Bioepis Co., Ltd. announced the availability of Epysqli (eculizumab-aagh) in the U.S. Epysqli is a biosimilar to Soliris (eculizumab) for the… read more.

FDA grants Isturisa (osilodrostat) expanded indication for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome – Recordati

Written by | 6 May 2025

Recordati announced that the FDA has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat),  for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for… read more.

Tivdak (tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic cervical cancer – Genmab

Written by | 5 May 2025

Genmab announced that the European Commission (EC) has granted marketing authorization for Tivdak  (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or… read more.

Second phase of ADVANTAGE AF study of FARAPULSE Pulsed Field Ablation System meets primary safety and efficacy endpoints – Boston Scientific

Written by | 4 May 2025

Boston Scientific announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the Farapulse Pulsed Field Ablation (PFA)… read more.

Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer – AstraZeneca

Written by | 3 May 2025

AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved… read more.

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