AstraZeneca and Merck have secured priority review from the US Food and Drug Administration (FDA) for Lynparza as a maintenance therapy for patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer.
Seattle Genetics has filed a supplemental Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of CD30-expressing peripheral T-cell lymphoma (PTCL), based on data from the phase 3 ECHELON-2 trial.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Lorbrena (lorlatinib) for previously-treated ALK-positive metastatic non-small cell lung cancer (NSCLC).
AbbVie and Roche have secured approval from the European Commission (EC) for the combination of Venclyxto (venetoclax) and MabThera (rituximab) to treat relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) in adult patients who had received at least one prior therapy.
Sandoz, a division of Novartis, has secured approval from the US Food and Drug Administration (FDA) for Hyrimoz (adalimumab-adaz), its biosimilar of AbbVie’s Humira (adalimumab) for use in all indications as the reference medicine.
The US Food and Drug Administration has refused to approve Regeneron’s pre-filled syringe version of eye-drug Eylea (aflibercept).
Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat acute, uncomplicated influenza, or flu in people aged 12 years and older.
Eiger BioPharmaceuticals has secured the Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for lonafarnib to treat both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies.
Vertex Pharmaceuticals (Europe) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kalydeco (ivacaftor) to treat people with cystic fibrosis (CF) aged 12 to <24 months with certain mutations in the CFTR gene.
Kala Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for KPI-121 0.25%, a topical product candidate being developed for the temporary relief of signs and symptoms of dry eye disease.
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