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- PMLiVE

AstraZeneca’s Tagrisso combination receives CHMP recommendation for advanced lung cancer

More than 450,000 people are diagnosed with lung cancer every year in Europe

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CHMP recommends Valneva’s chikungunya vaccine for use in adults

If approved, Ixchiq will become the first vaccine available in the EU for the mosquito-borne viral disease

- PMLiVE

Pfizer’s one-time haemophilia B therapy Durveqtix receives CHMP recommendation

More than 38,000 people worldwide are currently affected by the inherited bleeding disorder

- PMLiVE

Takeda’s enzyme replacement therapy recommended by CHMP for rare blood clotting disorder cTTP

If approved, rADAMTS13 will be the first and only enzyme replacement therapy in the EU indicated for cTTP

- 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

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