Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.
The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).
The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.
Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
The European Commission has granted orphan drug designation to the Soligenix recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax) for the prevention of ricin poisoning.
The US Food and Drug Administration (FDA) has expanded the indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Seattle Genetics’ Adcetris (Brentuximab Vedotin) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).
The US Food and Drug Administration (FDA) has accepted Pfizer and Astellas Pharma's supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for a new indication and granted priority review designation.
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