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Calquence Recommended for CHMP Approval for Chronic Lymphocytic Leukemia americanpharmaceuticalreview
July 31, 2020
AstraZeneca’s Calquence (acalabrutinib) has been recommended for marketing authorization in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults.
Janssen gets CHMP positive opinion for expanded use of IMBRUVICA, rituximab combo in CLL pharmaceutical-business-review
July 29, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA ...
Sobi to refile Gamifant following CHMP rejection pharmatimes
July 28, 2020
Sobi has announced its intent to file for a re-examination of Gamifant (emapalumab) in Europe following negative opinion by the European Medicines Agency's human medicines committee.
CHMP backs expanding scope of Kyowa Kirin's Crysvita pharmatimes
July 28, 2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding approval of Kyowa Kirin's Crysvita (burosumab) to include older adolescents and adults living with X-linked hypophosphataemia (XLH).
EMA recommends 11 new medicines for approval following July meeting europeanpharmaceuticalreview
July 28, 2020
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA’s CHMP, along with nine other medicines.
Eleven medicines backed for EU approval pharmatimes
July 27, 2020
The European Medicines Agency human medicines committee (CHMP) has backed eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the region and a novel treatment for multiple myeloma.
Novartis Receives Positive CHMP Opinion for New Xolair Indication americanpharmaceuticalreview
July 09, 2020
Novartis announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Xolair® (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) ...
Cosentyx Gains Positive CHMP Opinion for Pediatric Psoriasis americanpharmaceuticalreview
July 08, 2020
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and ...
CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation europeanpharmaceuticalreview
July 03, 2020
The European Medicines Agency’s human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation europeanpharmaceuticalreview
July 03, 2020
The European Medicines Agency’s human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.

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