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- PMLiVE

Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP

Doses will be ready to ship immediately upon authorisation by the European Commission

- PMLiVE

Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns

Evrysdi is already approved in the EU to treat SMA patients aged two months or older

- PMLiVE

Bristol Myers Squibb’s Opdivo recommended by CHMP for expanded melanoma use

The global incidence of skin cancer has been rising steadily over the past few decades

- PMLiVE

Merck granted positive CHMP opinion for Keytruda combination in gastric cancer

Over one million new cases of gastric cancer were diagnosed globally in 2020

- PMLiVE

Janssen receives positive CHMP opinion for Talvey in multiple myeloma

More than 50,900 people in Europe were diagnosed with multiple myeloma in 2020

- PMLiVE

Sandoz granted positive CHMP opinion for multiple sclerosis biosimilar

The neurological disease affects approximately 2.8 million people worldwide

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EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The EU regulator concluded that the benefits of Adakveo did not outweigh its risks

- PMLiVE

GSK’s RSV vaccine candidate recommended by CHMP for older adults

RSV infections in older adults account for over 270,000 hospitalisations each year in Europe

- PMLiVE

Novartis’ Cosentyx recommended by CHMP for hidradenitis suppurativa

An estimated one in 100 people globally are affected by the inflammatory skin disease

- PMLiVE

Bristol Myers Squibb’s plaque psoriasis treatment recommended by CHMP

At least 100 million people worldwide are impacted by some form of psoriasis

- PMLiVE

Sanofi/Regeneron’s Dupixent recommended by CHMP for atopic dermatitis in children

If approved, the medicine would be the first and only targeted option in the EU for this age group

- PMLiVE

Sandoz’s high concentration Hyrimoz formulation recommended for use in EU

The recommendation includes multiple indications such as rheumatoid arthritis and Crohn’s disease

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