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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Teva announces Austedo XR (deutetrabenazine) extended release tablets now US FDA approved as a one pill, once daily treatment option for clinically therapeutic doses (24 mg–48 mg/day)

29 May 2024 - US FDA approves new one pill, once daily Austedo XR tablets (30 mg, 36 mg, 42 ...

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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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Dupixent recommended for EU approval by the CHMP to treat patients with COPD

31 May 2024 - Recommendation for adults with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils based on data from ...

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AbbVie receives positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis

31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that ...

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New gene therapy treatment for haemophilia B

31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene ...

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First vaccine to protect adults from Chikungunya

31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...

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Moderna receives US FDA approval for RSV vaccine mRESVIA

31 May 2024 - mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes ...

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Highlights from the 27-30 May 2024 CHMP meeting

31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...

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US FDA approves Bristol Myers Squibb’s Breyanzi as a new CAR T-cell therapy for relapsed or refractory mantle cell lymphoma

30 May 2024 - In the MCL cohort of TRANSCEND-NHL-001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion ...

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Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma

29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...

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Zanubrutinib in combination with obinutuzumab for the treatment of patients with relapsed or refractory B-cell follicular lymphoma after two or more treatments

28 May 2024 - NICE is unable to make a recommendation on the use of zanubrutinib (Brukinsa) in combination with obinutuzumab ...

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Dabrafenib mesylate in combination with trametinib dimethyl sulphoxide for the treatment of children and adolescents with BRAF V600E mutation positive glioma

29 May 2024 - NICE has published final evidence-based recommendations on the use of dabrafenib mesylate (Finlee) in combination with ...

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