Novartis has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Kisqali (ribociclib) as an adjuvant treatment for certain early breast cancer patients.
The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
The US Food and Drug Administration (FDA) has granted fast track designation for Volastra Therapeutics’ KIF18A inhibitor, VLS-1488, to treat patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).
The US Food and Drug Administration (FDA) has granted fast track designation for Elevation Oncology’s EO-3021, a treatment for patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AbbVie’s mirvetuximab soravtansine in adults with a specific type of ovarian cancer.
Bayer has announced a strategic partnership with NextRNA Therapeutics to develop long non-coding RNAs (lncRNAs)-targeting small molecule therapeutics for cancer treatment.
Zuellig Pharma has entered into an exclusive distribution agreement with Regeneron Ireland DAC for the launch and commercialisation of Libtayo (cemiplimab) in the South Korean and Taiwanese markets.
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GSK's investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227).
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for AffyImmune’s CAR T-cell therapy, AIC100, to treat recurrent anaplastic thyroid cancer (ATC).
US-based Amneal Pharmaceuticals has announced the launch of FOCINVEZ, a ready-to-use injectable for the prevention of nausea and vomiting in chemotherapy patients.
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