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Ongentys

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Janssen’s Tecvayli approved by EC for reduced dosing frequency in multiple myeloma

Tecvayli was the first BCMA-targeting bispecific antibody to be approved in Europe

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Roche’s Genentech and Blueprint receive full FDA approval for Gavreto in lung cancer

The targeted therapy was granted accelerated approval for the NSCLC indication in 2020

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

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Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns

Evrysdi is already approved in the EU to treat SMA patients aged two months or older

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Roche partners with Alnylam on hypertension therapy in deal worth up to $2.8bn

Zilebesiran is in phase 2 development to treat hypertension in patients with high-unmet needs

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EU establishes €100m funding scheme for projects tackling public health threats

The HERA Invest fund will focus on health emergency prevention and preparedness initiatives

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Roche’s Ocrevus shows promise as a subcutaneous injection in phase 3 MS trial

The therapy is already approved for certain MS patients as a twice-yearly intravenous infusion

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Roche’s fixed-duration lymphoma treatment approved by European Commission

Approximately 36,000 people are diagnosed with DLBCL each year in Europe

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Novavax’s COVID-19 vaccine granted full marketing authorisation in EU

The EC’s decision was supported by positive results from a phase 3 trial evaluating Nuvaxovid

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FDA declines to approve Amneal Pharmaceuticals’ Parkinson’s disease treatment

The regulator said the safety for one of the drug's ingredients had not been adequately established

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Roche’s Evrysdi shows continued improvement in children with spinal muscular atrophy

The progressive neuromuscular disease affects approximately one in every 10,000 babies

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European Commission approves Amicus Therapeutics’ Pompe disease therapy

The company can now offer Opfolda together with its previously-approved Pombiliti

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