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Regeneron’s Praluent receives FDA approval for paediatric patients with genetic high cholesterol

Patients aged eight year or older with heterozygous familial hypercholesterolaemia will be eligible to receive the treatment

- PMLiVE

Bristol Myers Squibb’s Opdivo combination receives FDA approval for urothelial carcinoma

More than 83,000 news cases of bladder cancer are expected to be diagnosed in the US this year

- PMLiVE

BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

Approximately 15,000 new cases of follicular lymphoma are diagnosed in the US every year

- PMLiVE

Sandoz receives FDA approval for first denosumab biosimilars Wyost and Jubbonti

The biosimilars have been authorised for all indications covered by Amgen's reference medicines

- PMLiVE

Merck KGaA and C4 Therapeutics enter protein degrader partnership worth $756m

The collaboration will utilise C4T’s TORPEDO platform to target and degrade disease-associated proteins

- PMLiVE

Johnson & Johnson’s Rybrevant granted FDA approval for lung cancer indications

The drug was previously authorised for use by the US regulator under the accelerated approval pathway

- PMLiVE

BMS shares positive long-term results for Zeposia in relapsing multiple sclerosis

Zeposia is already approved in major markets for relapsing MS and ulcerative colitis

- PMLiVE

New genetic risk tool could predict multiple sclerosis in young adults much earlier

Approximately 2.8 million people worldwide are affected by the disabling neurological disease

- PMLiVE

FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

- PMLiVE

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

- 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

Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

More than 35,000 cases of the blood cancer are expected to be diagnosed in the US this year

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