News Wire

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments. This patient received the treatment in a clinical trial led by Steven A. Rosenberg, MD, PhD,…
The FDA has approved an additional indication for tofacitinib (Xeljanz, Pfizer). The drug is approved for administration at 10 mg twice daily for at least eight weeks, followed by 5 mg twice daily or 10 mg twice daily, for the treatment of adult patients with moderately to severely active ulcerative…
The FDA has approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting…
The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital and the University of Toronto. Published in the Journal of the American College of Cardiology, the systematic review of existing…
The FDA is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency has announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants…
The FDA has approved pegvaliase-pqpz (Palynziq, BioMarin Pharmaceutical, Inc.) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity…
U.S. health authorities are preparing to send an experimental Ebola treatment to the Democratic Republic of Congo for use in a clinical trial aimed at stemming an outbreak in the country that has spread to Mbandaka, a city of about 1.5 million people, Reuters reports. The trial would test the effectiveness…
Roche has announced that the Phase 3 IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The combination of atezolizumab (Tecentriq, Roche) plus chemotherapy (carboplatin and albumin-bound paclitaxel; nab-paclitaxel [Abraxane, Celgene Corp.]) helped…
The FDA has approved avatrombopag (Doptelet, AkaRx, Inc.) tablets to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.  “Patients with chronic liver disease who have low…
The FDA has approved erenumab-aooe (Aimovig, Amgen, Inc.) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Erenumab is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin…
The FDA has approved lofexidine hydrochloride (Lucemyra, US WorldMeds LLC) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While lofexidine may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for…
The FDA has approved Retacrit (epoetin alfa-epbx, Hospira, Inc.) as a biosimilar to Epogen (epoetin alfa, Amgen, Inc.) and Procrit (epoetin alfa, Janssen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with human immunodeficiency virus infection.…
The surge in U.S. kids taking medication for attention-deficit/hyperactivity disorder (ADHD) is having an unintended side effect, a new study suggests: more children and teens are overdosing on these drugs. Nationwide, U.S. Poison Control Centers received more than 156,000 calls about exposures to ADHD…
The FDA has approved an expanded indication for fingolimod (Gilenya, Novartis) to treat relapsing multiple sclerosis (MS) in children and adolescents 10 years of age and older. This is the first FDA approval of a drug to treat MS in pediatric patients. “For the first time, we have an FDA-approved…
The Department of Justice has joined whistleblower litigation accusing Insys Therapeutics, Inc., of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications, Reuters reports. The government’s involvement was disclosed in a filing made public earlier this…

Pages