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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

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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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EC approves Celltrion’s omalizumab biosimilar Omlyclo for immunological conditions

The drug can be used to treat patients with conditions including chronic spontaneous urticaria

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Trial reveals promising results for radiotherapy/hormone therapy combination in prostate cancer

Further evidence is being sought from the phase 2 TRAP trial results through the larger STAR-SHIP study

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Sobi’s Aspaveli receives expanded EC approval for rare blood disorder PNH

The C3 therapy can now be used as a first-line treatment for paroxysmal nocturnal haemoglobinuria

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BeiGene’s Tizveni receives EC approval to treat non-small cell lung cancer

Under the brand name Tevimbra, the company will combine the NSCLC indications with the second-line ESCC indication in late 2024

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J&J and Legend’s Carvykti receives EC approval to treat relapsed and refractory multiple myeloma

The BCMA-targeted therapy is the first to receive approval in Europe for RRMM patients as early as first relapse

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Astellas announces EC approval of Xtandi for expanded prostate cancer use

Up to 40% of patients who have undergone definitive prostate cancer treatment will experience biochemical recurrence within ten years

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AstraZeneca’s Voydeya granted EC approval to treat rare blood disease PNH

The factor D inhibitor has been authorised for use alongside the company’s complement C5 inhibitors

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Pfizer’s antibiotic combination receives EC approval to treat multidrug-resistant infections

Antimicrobial resistance has been declared by WHO as one of the top ten threats to global health

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UCB’s Bimzelx granted EC approval to treat hidradenitis suppurativa in adults

The regulator’s decision marks Bimzelx’s fourth approved indication within the EU

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