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).
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.
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.
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.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).
Shield Therapeutics has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its lead product Feraccru to treat iron deficiency.
GW Pharmaceuticals said that EPIDIOLEX (cannabidiol) oral solution has been transferred to Schedule V restriction classification, by the US Drug Enforcement Administration (DEA).
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