Branded

Loxo, Bayer get FDA nod for Vitrakvi

The FDA has approved Vitrakvi, an oncology treatment that is based on tumor genetics.
Pfizer gets FDA green light for Daurismo

The FDA's approval of Pfizer's Daurismo provides a treatment for adults age 75 years old or older with acute myeloid leukemia.
FDA approves Gamifant for ultra-rare illness

Sobi and Novimmune will bring Gamifan to patients with HLH, an ultra-rare syndrome of hyper-inflammation.
FDA clears new indication for Promacta

The FDA's approval for a new indication for Promacta provides a new treatment for a rare life-threatening disease.
Aries gets FDA green light for Aemcolo

Aries' Aemcolo (rifamycin) is the first antibiotic approved for travelers' diarrhea in over a decade.
Indivior gets FDA nod for Perseris

Indivior’s once-monthly Perseris now offers a new option for treating adults with schizophrenia.
FDA clears new indication for Adcetris

Seattle Genetics' Adcetris injection (brentuximab vedotin) has received the FDA's nod to be used in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma.
Janssen gets FDA green light for new Invokana indication

Janssen's oral diabetes treatment is the first oral diabetes treatment to have an indication to reduce the risk of heart attack, stroke or cardiovascular death, the company said.

Mallinckrodt to spin specialty generics business off to shareholders