EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14

24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...

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Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe

23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...

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Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly

23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...

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Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe

22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...

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Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews

20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...

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Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH

8 May 2024 - Sobi today announced that the European Commission has approved an indication extension for Aspaveli (pegcetacoplan) for ...

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EMA validates Bristol Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer

6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...

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Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease

1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...

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Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis

29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer ...

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Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER positive breast cancer

29 April 2024 - Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression ...

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Highlights from the 22-25 April 2024 CHMP meeting

26 April 2024 - The EMA’s CHMP recommended eight medicines for approval at its April 2024 meeting. ...

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Biogen receives positive CHMP opinion for Tofidence (tocilizumab), a biosimilar referencing RoActemra

25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...

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Pierre Fabre Laboratories receive positive CHMP opinion for Obgemsa (vibegron) in overactive bladder syndrome

26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...

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Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer

26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...

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Johnson & Johnson receives positive CHMP opinion for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...

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