FDA Approvals

Diabetic patients challenge insulin makersIn the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.
Will Trump’s FDA picks speed drug approvals?Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.
First therapy approved for rare blood cancerFDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.
Constipation drug wins approvalFDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
Long-acting opioid painkiller wins approvalFDA recently approved a long-acting opioid designed to deter abuse.
FDA approves hemophilia A drug for childrenFDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
Why 2016 drug approvals fell
Why 2016 drug approvals fellWhile FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
New device could be breakthrough for diabeticsFDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.
Advanced ovarian cancer drug approvedFDA 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.
FDA green lights first treatment for rare spinal diseaseFDA 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.