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Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma – Regeneron Pharma

Written by | 3 Sep 2024

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse… read more.

UCB to accelerate innovation and strategic partnerships, divesting mature product portfolio in China to CBC Group.

Written by | 2 Sep 2024

UCB, a global biopharmaceutical company, announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets…. read more.

FDA clearance of the HYDROS Robotic System, the next-generation, AI-powered platform for aquablation therapy – PROCEPT BioRobotics Corporation

Written by | 1 Sep 2024

PROCEPT BioRobotics Corporation announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI treatment planning, advanced… read more.

Leqembi (lecanemab) authorized for early alzheimer’s disease in Great Britain – Eisai + Biogen

Written by | 31 Aug 2024

Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the… read more.

FDA approval & authorization for Omicron KP.2-adapted COVID-19 Vaccine – BioNTech SE + Pfizer

Written by | 30 Aug 2024

Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA),… read more.

Update on cannabidiol oral solution phase III trial in Japan in treatment-resistant epilepsies – Jazz Pharma

Written by | 29 Aug 2024

Jazz Pharmaceuticals plc announced top-line results from the Phase III open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex/Epidyolex globally)… read more.

First real-world analysis of Ebola vaccine reveals 84% effectiveness during Democratic Republic Congo outbreak – Merck Inc

Written by | 28 Aug 2024

When a deadly outbreak of the Ebola virus spread through the Democratic Republic of Congo in 2018, Merck’s then-unapproved vaccine (Ervebo) was quickly deployed to help address the… read more.

Abbott advances heart failure management with aspirin free regimen for patients receiving the HeartMate 3 heart pump

Written by | 27 Aug 2024

Abbott announced that the FDA has approved a change to its label that will help patients who receive a HeartMate 3 left ventricular assist device (LVAD, or heart… read more.

FDA approval for IPX 203 for treatment of Parkinson’s disease to be launched as Crexont (carbidopa and levodopa) extended-release capsules – Amneal Pharma

Written by | 26 Aug 2024

Amneal Pharmaceuticals, Inc., announced that the FDA has approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). Crexont is a novel, oral formulation… read more.

European Medicines Agency validates application for CAR-T cell therapy Breyanzi, for relapsed or refractory follicular lymphoma – BMS

Written by | 25 Aug 2024

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed… read more.

Fasenra (benralizumab) approved in China for the treatment of severe eosinophilic asthma – AstraZeneca

Written by | 24 Aug 2024

AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older… read more.

FDA approves for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis – Galderma

Written by | 23 Aug 2024

Galderma announced that the FDA has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. Nemluvio was granted Breakthrough… read more.

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