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FDA approves Vtama (tapinarof) cream, 1%to treat atopic dermatitis – Organon

Written by | 29 Dec 2024

Organon announced that the FDA has approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD)… read more.

The journal Brain Stimulation has published two pivotal articles chronicling the unipolar cohort data set for the RECOVER clinical study of the VNS therapy system – LivaNova

Written by | 28 Dec 2024

LivaNova PLC announced that the journal Brain Stimulation has published two pivotal articles chronicling the unipolar cohort data set for the RECOVER clinical study. The researchers evaluated the… read more.

Complete Response for Andexxa (andexanet) to convert accelerated approval to full approval to reverse the effects of direct-oral anticoagulants – AstraZeneca

Written by | 27 Dec 2024

AstraZeneca PLC’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, after the FDA  issued a complete response letter for the supplemental biologics license application. The… read more.

FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity – Eli Lilly

Written by | 26 Dec 2024

Eli Lilly and Company announced the FDA approved Zepbound (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound… read more.

NICE (UK) managed access for Elrexfio (elranatamab) for treating relapsed and refractory multiple myeloma after 3 or more treatments – Pfizer

Written by | 24 Dec 2024

NICE (UK) 1.1 Elranatamab is recommended with managed access as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of… read more.

FDA approves Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis – Galderma

Written by | 23 Dec 2024

Galderma announced that the FDA has approved Nemluvio (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS)… read more.

CHMP positive for Osenvelt (denosumab biosimilar) for treatment of bone diseases – Celltrion

Written by | 22 Dec 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Osenvelt (denosumab biosimilar), intended for the prevention… read more.

CHMP positive for Kostaive vaccine for the prevention of COVID 19 in adults – CSL Behring + Arcurtus

Written by | 21 Dec 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kostaive, a vaccine intended for the prevention of… read more.

Blenrep shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse – GSK

Written by | 20 Dec 2024

GSK plc announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating Blenrep (belantamab mafodotin) in combination with… read more.

CHMP positive for Stoboclo (denosumab biosimilar) intended for the treatment of osteoporosis in post menopausal women, bone loss in men and treatment of systemic glucocorticoid – Celltrion

Written by | 19 Dec 2024

On 12 December 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Stoboclo (denosumab… read more.

Five-year results confirm Roche’s Polivy combination therapy as new standard of care for previously untreated aggressive lymphoma

Written by | 18 Dec 2024

Roche announced  data from a 5-year follow-up of the pivotal phase III POLARIX study. Data were presented in an oral session at the 66th American Society of Hematology… read more.

NMPA (China) approves Welireg (belzutifan), for the treatment of adult patients with von Hippel-Lindau disease – Merck Inc

Written by | 17 Dec 2024

Merck Inc. (known as MSD outside of the United States and Canada), announced that the National Medical Products Administration (NMPA) in China has approved Welireg (belzutifan), for the… read more.

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