Bristol-Myers Squibb (BMS) said that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding approval for the expanded use of IMBRUVICA (ibrutinib).
Roche has secured priority review from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with chemotherapy as the first-line treatment of a form of triple-negative breast cancer (TNBC).
Clinical-stage biopharmaceutical firm Pain Therapeutics has petitioned the Food and Drug Administration (FDA) regarding a complete response Letter (CRL) for Remoxy issued in August this year.
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).
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