Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.
FDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.
FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
FDA recently approved a long-acting opioid designed to deter abuse.
FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
FDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.
FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.
FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
A new combination drug for type 2 diabetes will available in the US in the coming months.