argenx receives positive CHMP opinion for efgartigimod for the treatment of adult patients with generalised myasthenia gravis in Europe

24 June 2022 - Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and ...

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U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy

24 June 2022 - In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30 year ...

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First gene therapy to treat severe haemophilia A

24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...

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Highlights from the 20-23 June 2022 CHMP meeting

24 June 2022 - EMA’s CHMP recommended nine medicines for approval at its June 2022 meeting. ...

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Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV

24 June 2022 - Recommendation is based on week 26 data from the CAPELLA trial showing twice yearly lenacapavir achieved high ...

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Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia

24 June 2022 -  ...

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European Commission approves Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa

23 June 2022 - Filsuvez will be the first and only approved treatment for epidermolysis bullosa patients. ...

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Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer

23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...

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EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU

23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...

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EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17

23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...

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Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab injection) by China NMPA in combination with chemotherapy as first-line treatment for oesophageal squamous cell carcinoma

20 June 2022 -  Innovent Biologics and Eli Lilly today announced that the Center for Drug Evaluation of China's National ...

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NICE opts to reject Acorda’s MS drug Fampyra

22 June 2022 - NICE has announced its decision to reject Fampyra – also known as fampridine – for use ...

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Novartis receives European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer

22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...

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Novartis Tafinlar and Mekinist receives FDA approval for first tumour agnostic indication for BRAF V600E solid tumours

22 June 2022 - Approval supported by results from Phase II ROAR and NCI-MATCH studies demonstrating overall response rates up to ...

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U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children

22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...

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