CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment

15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...

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CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma

15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...

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Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis

15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...

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Highlights from the CHMP 11-14 November 2019 meeting

15 November 2019 - Seven new medicines recommended for approval. ...

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Dutch authorities hand over final building to EMA in Amsterdam

15 November 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in ...

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Regulators’ advice can make a difference for faster patient access to highly innovative therapies

12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...

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Actelion withdraws regulatory filings to extend the indication of Opsumit (macitentan 10mg) in CTEPH

12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings ...

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EMA publishes agenda for 11-14 November CHMP meeting

11 November 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Merck’s Ervebo [Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live] granted conditional approval in the European Union

12 November 2019 - Authorisation represents significant advancement in the global response to Ebola. ...

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‘Regulatory science to 2025’: live broadcast of post-consultation workshop

11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...

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Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen

7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...

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EMA validates Bratovi, Mektovi application for some mCRC

7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...

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One shot drug to end Sicilian curse comes at $1.8 million cost

5 November 2019 - A new targeted gene therapy shows the promise and pitfalls of medical advances. ...

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Octapharma’s fibryga receives European label extension to treat acquired fibrinogen deficiency (AFD)

5 November 2019 - Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of ...

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Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis

31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...

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