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- PMLiVE

AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer

Gastric cancer is the fifth highest cause of cancer deaths worldwide, with almost a million people diagnosed annually

- PMLiVE

Sanofi’s Rezurock receives positive CHMP opinion for chronic graft-versus-host disease

Up to 50% of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD

- PMLiVE

Sanofi and Regeneron’s Dupixent receives positive NICE final draft guidance for COPD

Around 1.4 million people in the UK are diagnosed with COPD, with two million thought to be undiagnosed

- PMLiVE

Regeneron’s Libtayo receives EC approval for skin cancer

Phase 3 trial results showed the drug significantly improved disease-free survival

- PMLiVE

Roche’s Lunsumio receives positive CHMP opinion for follicular lymphoma

The recommendation for the subcutaneous formulation follows encouraging trial data

- PMLiVE

EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

- PMLiVE

Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

- PMLiVE

Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

- PMLiVE

EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy

This follows preliminary results from the company's ongoing phase 2 trial

- PMLiVE

FDA approves Pfizer and BioNTech’s jab for COVID-19

Globally, five billion doses of the companies’ vaccine have been distributed

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CHMP recommends BeOne Medicines’ Tevimbra for new lung cancer indication

Non-small cell lung cancer accounts for up to 90% of all lung cancer cases

- PMLiVE

Eli Lilly’s Alzheimer’s disease drug donanemab recommended by CHMP

Up to 6.9 million people in Europe are affected by the neurodegenerative disorder

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