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This article highlights some of the key regulatory approvals granted…
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
The newly authorised formulation of the anti-CD20 therapy provides certain…
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
Spinal muscular atrophy (SMA) patients in the long-term extension Evrysdi…
Spinal muscular atrophy (SMA) patients in the long-term extension Evrysdi study maintained or improved key developmental skills over the five-year period, data shows.
The novel approval provides a dedicated therapy option for patients…
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending…
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
The subcutaneous injection of the novel cancer immunotherapy Tecentriq® (atezolizumab)…
16 January 2024 | By
The subcutaneous injection of the novel cancer immunotherapy Tecentriq® (atezolizumab) could provide a quicker alternative to intravenous infusion, research shows.
The assets Roche will gain rights to through its planned…
The assets Roche will gain rights to through its planned acquisition of Carmot Therapeutics include several incretin treatments with best-in-class potential in obesity and diabetes.
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s…
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
Roche is set to gain rights to develop, manufacture and…
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
OCREVUS subcutaneous injection was comparable to intravenous (IV) infusion in…
OCREVUS subcutaneous injection was comparable to intravenous (IV) infusion in providing near-complete suppression of multiple sclerosis brain lesions over 24 weeks, Phase III study data shows.
Roche has provided the first evidence that its oral anaplastic…
Roche has provided the first evidence that its oral anaplastic lymphoma kinase (ALK) inhibitor for non-small cell lung cancer (NSCLC) could be key in treating the early-stage disease.
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in…
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
Data shared at the 2023 American Society of Retina Specialists…
Data shared at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting will reveal new clinical and real-world evidence for the first bispecific antibody (bsAb) approved for the eye.
A Phase III trial for the only therapy approved for…
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
European approval of the bispecific antibody treatment has the potential…
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
