Takeda receives approval from European Commission for Fruzaqla in previously treated metastatic colorectal cancer

21 June 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...

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European Medicines Agency validates Bristol Myers Squibb’s application for subcutaneous nivolumab

21 June 2024 - Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation ...

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Truqap plus Faslodex approved in the EU for patients with advanced oestrogen receptor positive breast cancer

20 June 2024 - Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or ...

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European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A

19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...

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European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance

10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...

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Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix

4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...

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Nidlegy marketing authorisation application submitted to EMA

4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...

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CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC

1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...

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Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS

30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...

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Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer

3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...

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Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer

31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...

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Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo for the treatment of IgA nephropathy

30 May 2024 - Calliditas Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending the ...

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Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...

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Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for the treatment of PFIC in patients three months of age and older

31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...

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Takeda receives positive CHMP opinion for recombinant ADAMTS13 (rADAMTS13) in congenital thrombotic thrombocytopenic purpura

31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...

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