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- PMLiVE

risankizumab-rzaa

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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

Pfizer’s Velsipity receives MHRA and NICE authorisations to treat ulcerative colitis

The immune-mediated inflammatory bowel disease affects approximately 300,000 people in the UK

- 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

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

AbbVie gains rights to OSE’s chronic inflammation therapy in deal worth $713m

The company will gain an exclusive global license to develop, manufacture and commercialise OSE-230

- 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

AbbVie and Tentarix partner to develop oncology and immunology biologics

The collaboration will use Tentarix's proprietary platform to develop biologics against two targets

- PMLiVE

AbbVie’s Produodopa rolled out by NHS England for advanced Parkinson’s patients

The roll out follows NICE’s recommendation of the treatment in October 2023

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