FDA Approves Second CAR T-Cell Therapy
The second therapy of this innovative immunotherapy has received FDA approval to treat patients with relapsed/refractory aggressive B-cell NHL. FDA Approvals
News Alert
Trump’s Pick for Drug Czar Pulls Out After Investigation
The decision follows a report by the Washington Post and 60 Minutes that showed Rep. Tom Marino spearheaded legislation that made it harder for the government to police the pharmaceutical industry. Medscape Medical News
FDA Clears New Robotic Surgery System
The Senhance System (TransEnterix Surgical Inc) includes unique technological characteristics and is intended for use in laparoscopic colorectal and gynecologic surgery. FDA Approvals
FDA Clears Ustekinumab (Stelara) for Plaque Psoriasis in Teens
For at least two thirds of patients aged 12 to 17 years who were treated with ustekinumab, cleared skin or minimal psoriasis was achieved at week 12 in a phase 3 study. FDA Approvals
GSK Shingles Vaccine Shingrix Gets First Okay in Canada
Shingrix, given in two doses 2 to 6 months apart, is for adults aged 50 years and older. It was shown to achieve ≥90% efficacy in clinical trials. International Approvals
Trump Axes ACA Cost-Sharing Subsidy Payments to Insurers
The decision represents another effort by the White House to dismantle the ACA after Congressional Republican attempts failed. Medscape Medical News
Trump Signs Executive Order to Allow Cheaper Health Plans
The executive order would lift restrictions on association health plans, letting them sell less expensive, skimpier plans; short-term insurance plans, lasting for up to a year, could be sold. Medscape Medical News
Trump Signs Order to Expand Low-Cost, Low-Benefit Plans
The president directs departments to develop new regulations allowing expansion of association health plans and limited-duration policies, potentially imperiling ACA exchanges. Medscape Medical News
FDA OKs First 7T MRI Offering More Magnetism, Sharper Images
The FDA is limiting the use of the new Magnetom Terra system to imaging the head, arms, and legs of patients who weigh more than 66 pounds. FDA Approvals
FDA Clears Injectable Ascorbic Acid (Ascor) for Scurvy
Ascor is for the short-term treatment of scurvy in adults and children aged 5 months and older for whom oral administration is not possible, is insufficient, or is contraindicated. FDA Approvals
Implant to Treat Central Sleep Apnea Approved by FDA
The Remedē System treats moderate-to-severe central sleep apnea by stimulating a nerve to move a patient’s diaphragm when the brain doesn’t. FDA Approvals
FDA OKs First Extended-Release Corticosteroid Shot for Knee OA
Triamcinolone acetonide extended-release injectable suspension (Zilretta) is a nonopioid option that provides knee OA pain relief over 12 weeks. FDA Approvals
FDA OKs First Test to Screen Zika Virus in Donated Blood
The cobas Zika test from Roche Molecular Systems is intended for blood collection establishments, not clinicians who want to diagnose individuals. FDA Approvals
FDA: Blindness Risk From Compounded Vancomycin Eye Injections
The FDA is warning against intraocular injections of vancomycin either alone or in combination with other drugs, in light of a new case of hemorrhagic occlusive retinal vasculitis. News Alerts
FDA OKs Botox for Forehead Lines, Its Third Facial Indication
OnabotulinumtoxinA (Botox Cosmetic, Allergan) is now indicated for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. FDA Approvals
Second-Generation Rapid Influenza Test Clears FDA
The new Alere influenza test provides faster results, more flexible sampling features, and enhanced quality control functions compared with the first-generation test. FDA Approvals
Nobel Prize in Medicine Awarded to Circadian Rhythm Researchers
‘Paradigm-shifting’ discoveries by the trio of Nobel laureates established key mechanistic principles for the biological clock. Medscape Medical News
FDA Approves New Fast-Acting Insulin, Fiasp, for Diabetes in Adults
The US FDA has approved ultrafast-acting mealtime insulin, Fiasp, designed to be taken just before or within 20 minutes of a meal. FDA Approvals
FDA Warns of Uptick in Endoleaks With Endovascular Grafts
Recent data suggest an increase in type IIIa and IIIb endoleaks with endovascular graft systems used for endovascular abdominal aortic and aortoilliac aneurysm repair, the FDA warns. News Alerts
FDA Approves Abemaciclib (Verzenio) for Advanced HR+ Breast Cancer
The new drug is similar to two other cyclin-dependent kinase (CDK) 4/6 inhibitors, but it also has some distinguishing qualities. FDA Approvals