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Thorinane

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Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

- PMLiVE

EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

- PMLiVE

Eisai and Biogen’s new data shows Alzheimer’s patients choose to stay on Leqembi long-term

The findings were presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases in Denmark

- 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

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

- PMLiVE

Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

- PMLiVE

Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment

The MHRA approval for IV dosing comes following positive results from the global phase 3 trial

- 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

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

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