SPOTLIGHT -
FDA Oks First Oral Blood Thinner for Children
The longstanding medicine for adults is now approved to treat children 3 months to less than 12 years old with venous thromboembolism.
FDA clears novel cancer treatments
Here are the top 2 novel cancer drugs cleared by the agency.
FDA approves landmark AI device to detect diabetic eye disease
FDA is permitting marketing of the first medical device that uses artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy.
FDA approves non-opioid drug for shoulder surgery
FDA approved a new indication for Exparel Bupivacaine Liposome injectable suspension (Exparel, Pacira) for use as a nerve block to produce post-surgical regional analgesia following shoulder surgery in adults.
FDA approves first-of-its kind diabetes management device
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics-the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
DTC drug ads don't show risks, study says
As FDA considers new guidelines on pharmaceutical product marketing, a new study found that pharma makers may not be following current FDA ad regulations.
Top 3 novel diabetes treatments
Over the past few months, several new diabetes treatments have been approved by FDA. Here are the top 3 novel drugs for diabetes.
FDA approves breakthrough drug for HIV patients with dwindling options
A new FDA-approved drug offers new hope for patients with multidrug-resistant HIV-1 infection.
Patient group pushes FDA to improve biosimilar education
FDA should provide better education about biosimilar drugs on the agency’s web site dedicated to biosimilars, a patient advocacy group said.
3 new FDA drug approvals
FDA recently approved 3 major drugs to treat lung cancer, prostate cancer, and cystic fibrosis. Here are the top 3 new drug approvals.
Opioid prescription limits gain support
A pharmacist organization is among the supporters of a new Medicare Part D proposal, which calls for a 7-day supply limit on opioid prescriptions.
DEA tightens fentanyl scheduling
Due to the increased use of illicit fentanyl mixed with heroin and used in counterfeit prescription drugs, the DEA placed all illicit fentanyl analogues not already regulated by the Controlled Substances Act into Schedule I.
Combo UTI drug can now treat costly pneumonias
FDA approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of ceftazidime and avibactam (Avycaz) to include 2 types of pneumonia.
FDA issues new warning on liver disease drug
FDA is adding a Boxed Warning, its most prominent warning, on a liver disease medicine.
Cannabis-derived epilepsy drug on the horizon
A pharmaceutical formulation of purified cannabidiol, a cannabinoid without euphoric side effects, is expected to launch in the second half of this year.
Blindness gene therapy price tag stirs controversy
A patient advocacy group is criticizing the hefty price tag of a new treatment for blindness.
Survey uncovers lupus corticosteroid treatment issues
Patients with systemic lupus erythematosus often self-manage their corticosteroid medication without the consent of their healthcare providers, according to a recent multicountry survey.
FDA takes tough stance on kids’ opioid cold meds
FDA is taking its toughest stance yet on opioid-containing cough and cold medications for children.
FDA approves first drug for breast cancer with BRCA gene
FDA approved the first drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
Drug shortage help on horizon
While hospitals continue to face IV saline shortages after two hurricanes significantly damaged infrastructure in Puerto Rico, the situation should improve early this year.
