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- PMLiVE

FDA approves Geron’s Rytelo to treat lower-risk myelodysplastic syndrome patients

The oligonucleotide telomerase inhibitor is administered as an intravenous infusion every four weeks

- 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

Bristol Myers Squibb’s Breyanzi receives FDA approval for mantle cell lymphoma

The rare form of non-Hodgkin lymphoma accounts for around 3% of all NHL cases

- PMLiVE

Moderna’s RSV vaccine mRESVIA granted FDA approval for use in older adults

The approval marks the first time an mRNA vaccine has been approved for a disease other than COVID-19

- PMLiVE

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

- PMLiVE

GSK to expand respiratory pipeline with $1.4bn Aiolos Bio acquisition

The deal includes a monoclonal antibody ready to enter phase 2 development for asthma

- 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

Merck granted positive CHMP opinion for Keytruda combination in gastric cancer

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

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