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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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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BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer

23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...

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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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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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Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease

22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...

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European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy

20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...

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EMA publishes agenda for 20-23 June 2022 CHMP meeting

20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...

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EFPIA and Vaccines Europe are deeply disappointed about the decision taken by World Trade Organization at the Ministerial Conference to endorse a TRIPS waiver for COVID-19 vaccines

17 June 2022 - Speaking about the waiver, EFPIA Director General, Nathalie Moll said. “The decision is a serious retrograde step ...

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