Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)

17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...

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BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia

17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...

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Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer

17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...

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Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira

17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...

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Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma

17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...

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Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer

17 September 2021 - FDA approval based on Phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with ...

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Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older

16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...

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Moderna announces Health Canada approves its COVID-19 vaccine

16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...

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Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19

16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...

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With remdesivir, the Federal Joint Committee assesses the additional benefit of an anti-viral COVID-19 drug for the first time

16 September 2021 - Do patients with COVID-19 have a better chance of surviving and recovering faster if they are treated ...

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Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison

16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...

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BioCryst’s HAE med Orladeyo wins NICE nod

16 September 2021 - BioCryst’s Orladeyo (berotralstat) has received a positive recommendation from NICE for preventing recurrent attacks of hereditary ...

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Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC

15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...

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Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit

15 September 2021 - Third new area of ​​application/those affected still live a good year on average - and thus ...

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U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma

15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...

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