Regulation

Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors

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.

BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC

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.

FDA approves Clovis’ Rubraca for recurrent ovarian 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.

US and European regulators accept AstraZeneca’s applications for cancer treatments

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).

FDA approves new indication for Amgen’s leukemia drug Blincyto

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’ Pedmark gets FDA breakthrough status

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).

Soligenix gets orphan drug designation from European Commission for RiVax to prevent Ricin poisoning

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.

FDA expands approval for Novartis’ Tasigna to treat children with rare form of leukemia

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).

FDA expands approval of Seattle Genetics’ Adcetris for advanced classical Hodgkin Lymphoma

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).