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CHMP positive for a label extension for Ixchiq a single-dose vaccine for the prevention of disease caused by the chikungunya virus – Valneva SE

Written by | 7 Apr 2025

Valneva SE, a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion… read more.

CHMP postive for Deqsiga intended for replacement therapy in people with primary or secondary immunodeficiencies and immunomodulation – Takeda

Written by | 6 Apr 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deqsiga, intended for replacement therapy in people… read more.

Olumiant (baricitinib) delivered high rates of hair regrowth for adolescents with severe alopecia areata in phase III BRAVE-AA-PEDS study – Eli Lilly

Written by | 5 Apr 2025

Late-breaking results from Eli Lilly and Company and Incyte found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4… read more.

CE Mark approved in Europe for the Volt PFA system to treat patients with atrial fibrillation – Abbott

Written by | 4 Apr 2025

Abbott announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has… read more.

FDA approves label changes for Sublocade (buprenorphine extended-release) including rapid initiation and alternative injection sites – Indivior

Written by | 3 Apr 2025

Indivior PLC announced that the FDA has approved label changes for Sublocade (buprenorphine extended-release ) including a rapid initiation protocol and alternative injection sites, marking a significant advancement… read more.

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.

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