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Medtronic announces strongly positive results for patients from procedural and design innovation of Evolut TAVR

Written by | 5 Jan 2025

Medtronic plc announced new data for the Evolut Transcatheter Aortic Valve Replacement System (TAVR) at PCR London Valves 2024. This new clinical evidence brings further insights to global… read more.

Supplemental approval of Opdivo + cisplatin + gemcitabine for treatment of unresectable urothelial carcinoma in Japan – Ono Pharma

Written by | 4 Jan 2025

Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K.  announced that Ono has received a supplemental approval of Opdivo (generic name: nivolumab) Intravenous Infusion (“Opdivo”), an anti-PD-1 antibody, in… read more.

FDA approves Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma – Checkpoint Therapeutics

Written by | 3 Jan 2025

Checkpoint Therapeutics, Inc. announced that the FDA has approved Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who… read more.

New and updated data for Roche’s fixed-duration Lunsumio at ASH 2024 reinforce its potential to improve outcomes for people with lymphoma – Roche

Written by | 2 Jan 2025

Roche announced  that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting &… read more.

Results from phase III NATALEE trial of Kisqal (ribociclib) + endocrine therapy show sustained reduction of recurrence in HER+/HER2- early breast cancer – Novartis

Written by | 31 Dec 2024

Novartis announced results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqal (ribociclib) that underscore the extended efficacy beyond the duration of treatment in… read more.

FDA grants approval of Crenessity (crinecerfont), a first-in-class treatment for children and adults with classic congenital adrenal hyperplasia – Neurocrine Biosciences

Written by | 30 Dec 2024

Neurocrine Biosciences, Inc. announced the FDA approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years… read more.

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.

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