Approvals

Pfizer’s Daurismo gets FDA approval to treat elderly adults with AML

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Daurismo (glasdegib) to treat adult patients with newly-diagnosed acute myeloid leukemia (AML) for whom intensive chemotherapy is not an option.

EC approves Takeda’s $62bn acquisition of Shire

Takeda Pharmaceutical has secured clearance from the European Commission (EC) for its proposed $62bn acquisition of Shire.

Sobi, Novimmune secure FDA approval for Gamifant to treat HLH

Swedish Orphan Biovitrum (Sobi) and Novimmune have secured approval from the US Food and Drug Administration (FDA) for their monoclonal antibody Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH).

Aries Pharmaceuticals gets FDA nod for Aemcolo to treat Travelers’ Diarrhea

The US Food and Drug Administration (FDA) has approved Aries Pharmaceuticals’ Aemcolo (rifamycin) 194mg delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.

FDA approves Novartis drug Promacta for first-line SAA

The US Food and Drug Administration (FDA) has expanded the label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST).

Pfizer gets FDA nod for lung cancer drug Lorbrena

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).

Novartis’ Sandoz division secures FDA approval for biosimilar Hyrimoz

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.

FDA approves Roche’s Xofluza to treat influenza

Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat acute, uncomplicated influenza, or flu in people aged 12 years and older.

AstraZeneca, Merck’s Lynparza gets FDA ODD for pancreatic cancer

AstraZeneca and Merck have secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to treat pancreatic cancer.