Regulation - Approvals

Finch gets FDA breakthrough therapy status for CP101 to treat recurrent C. Difficile infection

Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium difficile (C. difficile) infection.

Sanofi gets FDA nod for blood disorder drug Cablivi

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its blood-disorder drug Cablivi (caplacizumab-yhdp).

Merck’s 15-valent pneumococcal conjugate vaccine gets FDA breakthrough therapy designation

Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.

FDA approves Imbruvica combo for treatment-naive CLL patients

Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

EC approves Clovis’ Rubraca to treat women with relapsed ovarian cancer

Clovis Oncology has secured approval from the European Commission (EC) for its Rubraca (rucaparib) as maintenance treatment for women with relapsed ovarian cancer.

EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL

Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.

EC approves Vertex’s CF treatment Orkambi for children aged two to five years

Vertex Pharmaceuticals (Europe) has secured approval from the European Commission (EC) for Orkambi (lumacaftor/ivacaftor) to treat of children with cystic fibrosis (CF) aged two to five years old who have two copies of the F508del mutation.

Exelixis announces US FDA approval of CABOMETYX tablets for previously treated HCC

Exelixis announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).