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- PMLiVE

osteoporosis

Biogen Idec building

Biogen’s Actemra biosimilar approved by FDA to treat adult and paediatric arthritis

Tofidence is now the first biosimilar referencing Actemra to gain approval from the US regulator

regeneron headquarters

Regeneron’s odronextamab granted FDA priority review for non-Hodgkin lymphoma

The regulator is expected to make a decision on the drug by the end of March 2024

- PMLiVE

Sandoz biosimilar receives EC approval to treat MS

Tyruko is the first and only biosimilar treatment for relapsing-remitting MS in Europe

- PMLiVE

GSK’s Ojjaara receives FDA approval to treat myelofibrosis patients with anaemia

Myelofibrosis is a rare blood cancer affecting approximately 25,000 patients in the US

- PMLiVE

FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

The supply of cisplatin, carboplatin and methotrexate has nearly halved in the past year

- PMLiVE

Alnylam’s patisiran backed by FDA advisory committee for ATTR cardiomyopathy

Treatment options for the underdiagnosed and rapidly progressive condition are currently limited

- PMLiVE

FDA approves Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines

The vaccines have both been adapted to target the currently circulating XBB.1.5 Omicron variant

- PMLiVE

Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

The disease-modifying therapy is approved to treat all indications covered by Tysabri

- PMLiVE

Pfizer and Astellas’ Xtandi granted FDA priority review for new prostate cancer indication

The treatment is already approved in the US for three disease states of prostate cancer

- PMLiVE

Pfizer’s maternal RSV vaccine granted FDA approval to protect infants

The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy

regeneron headquarters

Regeneron’s Veopoz granted FDA approval for ultra-rare immune disease

Fewer than ten patients in the US have been diagnosed with CHAPLE disease

- PMLiVE

Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

The drug is the first-ever treatment approved in the US for patients with the disease

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