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Clinical reports

- PMLiVE

CSL’s Privigen approved as measles treatment by European Commission

Cases of measles have been rising in Europe since 2023

- PMLiVE

EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

- PMLiVE

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

Lilly’s early Alzheimer’s disease treatment approved in the EU

Marketing authorisation follows positive late-stage trial results

- 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

- PMLiVE

Sanofi’s Sarclisa approved by EC to treat newly diagnosed multiple myeloma

The drug is already approved in the EU across three other multiple myeloma indications

- PMLiVE

J&J announces EC approval of Imbruvica in previously untreated mantle cell lymphoma

The drug is already approved in the EU to treat relapsed or refractory cases of the blood cancer

- PMLiVE

Johnson & Johnson’s Darzalex approved by EC as first treatment for high-risk SMM

The early precursor of active multiple myeloma accounts for around 15% of all new multiple myeloma cases

- PMLiVE

Roche’s Itovebi granted EC approval to treat advanced breast cancer patients

Hormone receptor-positive breast cancer accounts for around 70% of all breast cancer cases

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