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FDA approves Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A or B with inhibitors – Novo Nordisk

Written by | 2 Apr 2025

Novo Nordisk announced that the FDA approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients… read more.

FDA approves Blujepa (gepotidacin) for treatment of uncomplicated urinary tract infections in female adults and paediatric patients 12 years of age and older – GSK

Written by | 1 Apr 2025

GSK plc announced that the FDA has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary… read more.

Talzenna (talazoparib) in combination with Xtandi (enzalutamide) improves survival outcomes in metastatic castration-resistant prostate cancer – Pfizer

Written by | 31 Mar 2025

Pfizer Inc. announced positive results from the Phase III TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor… read more.

New 48-week remission data on treatment of tardive dyskinesia with Ingrezza (valbenazine) capsules – Neurocrine Biosciences

Written by | 30 Mar 2025

Neurocrine Biosciences, Inc. presented new data from the long-term, open-label KINECT 4 study demonstrating remission of tardive dyskinesia among the majority of patients treated with once-daily Ingrezza (valbenazine) capsules…. read more.

NICE (UK) positive for Acarizax (12 SQ-HDM SLIT) for moderate to severe house dust mite allergic rhinitis – ALK

Written by | 29 Mar 2025

NICE (UK): 12 standard quality house dust mite sublingual lyophilisate (SQ-HDM SLIT) is recommended, within its marketing authorisation, as an option for treating moderate to severe house dust mite… read more.

New implementation study data shows zero cases of HIV with Apretude (cabotegravir extended release), the only long-acting injectable approved for HIV prep – ViiV Healthcare

Written by | 28 Mar 2025

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced new data from two implementation studies showing zero cases of… read more.

MHLW (Japan) approves Lunsumio (mosunetuzumab) to treat r/r follicular lymphoma – Chugai Pharma

Written by | 27 Mar 2025

Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Lunsumio for intravenous infusion 1mg” and “Lunsumio… read more.

Elahere (mirvetuximab soravtansine-gynx) shows consistent survival benefit in long-term analysis for certain ovarian cancer patients – AbbVie

Written by | 26 Mar 2025

AbbVie announced the final analysis of the confirmatory Phase III MIRASOL trial evaluating the efficacy and safety of Elahere  (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive… read more.

Phase III results from BRUIN CLL-321 show pirtobrutinib (Jaypirca) reduced the risk of disease progression or death by 46% – Eli Lilly

Written by | 25 Mar 2025

Eli Lilly announced results from the Phase III BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor in adult patients with chronic lymphocytic leukemia or… read more.

Braftovi (encorafenib) combination regimen significantly improved progression-free survival and overall survival in Phase III BREAKWATER trial – Pfizer

Written by | 24 Mar 2025

Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase III  BREAKWATER study of Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6… read more.

Positive results from the phase III C-POST trial for adjuvant treatment with Libtayo (cemiplimab) in cutaneous squamous cell carcinoma after surgery – Regeneron

Written by | 23 Mar 2025

Regeneron Pharmaceuticals, Inc. announced positive results from the Phase III C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo (cemiplimab) led to a statistically significant and… read more.

CHMP posiive for Calquence to treat mantle cell lymphoma – AstraZeneca

Written by | 22 Mar 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Calquence…. read more.

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