Novo Nordisk’s Awiqli approved by US FDA as once-weekly basal insulin for patients with type 2 diabetes
The insulin is designed as an alternative to daily basal insulin
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Regulatory
BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma
This type of cancer is the most common one diagnosed in teenagers
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AstraZeneca’s Imfinzi approved in EU for early gastric and gastro-oesophageal cancers
This is the first and only perioperative immunotherapy approved to treat early gastric cancers
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MHRA approves Leqselvi for severe alopecia areata
Around 30% of patients saw 80% more scalp hair after 24 weeks of treatment
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Bristol Myers Squibb’s Sotyktu approved by US FDA for psoriatic arthritis
Sotyktu is the first TYK2 inhibitor approved for active psoriatic arthritis
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Johnson & Johnson’s multiple myeloma treatment approved by US FDA
The approval was based on phase 3 data showing survival rates of 83.3% after three years
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J&J’s nipocalimab gets FDA Fast Track designation for lupus
The autoimmune disease affects approximately three to five million people globally
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Incyte Biosciences UK announces NICE approval for Opzelura for vitiligo
This is the first approved treatment option in the UK for patients with non-segmental vitiligo
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PureTech’s deupirfenidone gets FDA and EC Orphan Drug Designations for idiopathic pulmonary fibrosis
Rare diseases are defined as conditions affecting fewer than 200,000 people in the US or fewer than five in 10,000 individuals in the European Union
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Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input
While a lack of meal announcements can lead to lower glycaemic control, it reduces the mental burden for those with type 1 diabetes
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UCB’s Kygevvi receives positive CHMP opinion for thymidine kinase 2 deficiency
TK2d is an extremely rare disease characterised by severe and progressive muscle weakness
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AstraZeneca and Daiichi Sankyo’s Datroway given FDA Priority Review for breast cancer treatment
Approximately 70% of metastatic triple-negative breast cancer patients are ineligible for immunotherapy, creating an unmet medical need
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