FDA OKs New Molecular Assay for Blood Compatibility Testing
The ID CORE XT is the second molecular assay approved by FDA for use in transfusion medicine and the first to report genotypes as final results. FDA Approvals
News Alert
FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD
The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events. FDA Approvals
FDA Warns of Cyber Concerns With Implantable Pacemakers
Hacking concerns prompted the FDA to issue a safety alert and Medtronic to disable online updates for its CareLink 2090 and CareLink Encore 29901 programmers. News Alerts
FDA Approves Revcovi for Adenosine Deaminase SCID
The US Food and Drug Administration has approved elapegademase-lvlr for the treatment of adults and children with adenosine deaminase severe combined immune deficiency. FDA Approvals
FDA OKs Inotersen for Hereditary ATTR With Polyneuropathy
Inotersen treatment led to improvements in neurologic and quality-of-life endpoints in patients with hereditary transthyretin amyloidosis with polyneuropathy in a pivotal phase 3 trial. FDA Approvals
FDA Expands Gardasil to Include Adults Up to Age 45
The expanded age range for Gardasil 9 is an important opportunity to help prevent HPV-related diseases and cancers in a broader age range, the FDA said. FDA Approvals
U.S. FDA Expands Indication for Roche’s Bleeding Disorder Drug
Roche said on Thursday it received approval from U.S. regulators for its hemophilia A drug Hemlibra (emicizumab)for use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expir…
PRAC Again Warns Against Dolutegravir Use During Pregnancy
The European Medicines Agency has confirmed its earlier precaution regarding the use of dolutegravir in women who are or who could become pregnant; it expects to make final recommendations next year. News Alerts
PRAC Recommends Restrictions on Fluoroquinolone, Quinolones
The new restrictions follow a review of rare but disabling and potentially long-lasting side effects, mainly involving muscles, tendons, bones, and the nervous system. News Alerts
Senate Clears Final Opioid Package for Trump’s Signature
The bill would expand prescribing authority for certain drugs used in fighting addiction. It also mandates a study on effects of attempts to curb opioid use on patients in serious need of pain relief. Medscape Medical News
FDA Clears Omadacycline (Nuzyra) for ABSSSI and CABP
Omadacycline is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance. FDA Approvals
FDA Clears Omadacycline (Nuzyra) for Two Infections
Omadacycline is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance. FDA Approvals
FDA Approves Sarecycline for Moderate to Severe Acne
The FDA has approved sarecycline (Seysara, Almirall) for patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. FDA Approvals
FDA Clears First Autoinjectable Testosterone, Xyosted
Xyosted is the first self-injection testosterone replacement product for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone. FDA Approvals
FDA Clears Antibacterial Arikayce for MAC Lung Disease
Arikayce is the first drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and the first and only therapy specifically for MAC lung disease. FDA Approvals
FDA Expands Epilepsy Drug Perampanel (Fycompa) to Younger Kids
Although the drug is already approved as adjunctive treatment and monotherapy for partial-onset seizures in patients at least 12 years of age, the new approval expands use those as young as 4. FDA Approvals
New FreeStyle Libre With Alarms Approved for Diabetes in EU
The Libre 2.0 glucose-monitoring system includes optional customizable alarms for high and low glucose levels. International Approvals
Nobel Prize in Medicine Goes to Cancer Immunotherapy Pioneers
Nobel laureates James P. Allison and Tasuku Honjo discovered how the immune system can be harnessed to attack tumor cells, ushering in the era of immune checkpoint inhibitor therapy. Medscape Medical News
FDA Approves Cemiplimab, First Drug for Advanced CSCC
The US Food and Drug Administration today approved cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced, unresectable CSCC. FDA Approvals
FDA Freezes Imports From Chinese Maker of Tainted Valsartan
The FDA’s import alert bans all ingredients and finished drug products made by Zhejiang Huahai Pharmaceuticals from legally entering the United States. News Alerts