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- PMLiVE

JAK inhibitors

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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

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EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings

The reflection paper offers suggestions on trial design and strategies for minimising bias

- PMLiVE

EU outlines measures to mitigate antibiotic shortage across Europe

An unseasonably early upsurge in respiratory infections has led to the increase in demand

- PMLiVE

EU to revise pharmaceuticals law amid antibiotic shortages

The early upsurge in respiratory infections has led to a sudden increase in demand for antibiotics

- PMLiVE

Jasper Therapeutics’ briquilimab given orphan drug designation in EU

The drug will be used for transplant patients with SCID, AML and MDS

- PMLiVE

EMA’s emergency task force backs bivalent COVID-19 vaccines for primary vaccination

National authorities may decide to use the vaccines in their primary vaccination campaigns

- PMLiVE

BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

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