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- PMLiVE

Takeda’s Fruzaqla approved by EC to treat metastatic colorectal cancer in adults

Approximately 538,000 new cases of colorectal cancer were diagnosed in Europe in 2022

- PMLiVE

Bristol Myers Squibb’s Krazati granted FDA accelerated approval in colorectal cancer

More than 106,000 new cases of the disease are expected to be diagnosed in the US this year

- PMLiVE

Sobi receives EC marketing authorisation for Altuvoct in haemophilia A

The rare bleeding disorder affects approximately one in every 5,000 male births annually

- PMLiVE

Takeda shares long-term results for HyQvia in rare neurological disorder CIDP

The therapy is the first and only facilitated subcutaneous immunoglobulin treatment for CIDP

- PMLiVE

AstraZeneca’s Truqap plus Faslodex granted EC approval to treat advanced breast cancer

More than 550,000 new cases of breast cancer were diagnosed in Europe in 2022

- PMLiVE

Takeda shares late-stage results for investigational soticlestat in rare epileptic disorders

Dravet syndrome and Lennox-Gastaut syndrome are drug-resistant to many anti-seizure medications

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EMA announces launch of two advice pilots to improve clinical trials in Europe

The pilots are part of the Accelerating Clinical Trials in the EU initiative to foster high-quality clinical research

- PMLiVE

Roche’s ALK inhibitor Alecensa granted EC approval to treat early-stage lung cancer

Non-small cell lung cancer represents up to 85% of all lung cancer diagnoses

- 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

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Biogen’s Qalsody granted EC approval to treat rare form of ALS in adults

Mutations in the SOD1 gene are responsible for an estimated 2% of all ALS cases

- PMLiVE

Bristol Myers Squibb’s Opdivo approved by EC for adults with urothelial carcinoma

UC accounts for approximately 90% of all bladder cancers, the ninth most common cancer globally

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European Commission finalises joint clinical assessment rules for faster access to medicines

Established under the regulation on Health Technology Assessment, the new rules are set to commence in January 2025

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