Clinical News

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.
Drug distributor pays record fineMcKesson Corp., one of the largest distributors of pharmaceuticals, agreed to pay a record civil penalty for alleged violations of the Controlled Substances Act.
Constipation drug wins approvalFDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
Trump's drug pricing comments create debateWhile President-elect Donald Trump recently said that the pharmaceutical industry is “getting away with murder” in terms of drug prices, the industry is trying to self-regulate before facing tighter rules from the incoming administration.
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.
New 340B drug rule sets drugmaker finesConsumer health groups are praising Health and Human Services’ (HHS) new rule on the Medicaid 340B drug discount program, which sets a ceiling on drug prices.
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.