News from the FDA/CDC
Feature
Vibrating pill can help treat constipation
The drug-free pill is designed for daily use.
News from the FDA/CDC
FDA OKs sacituzumab govitecan for HR+ metastatic breast cancer
Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial.
News from the FDA/CDC
Massive rise in drug overdose deaths driven by opioids
The total number of deaths caused by drug overdose exceeded 100,000 for the first time ever in 2021.
News from the FDA/CDC
CDC reports uptick in invasive Strep A infections
Consider this bacterial infection as a possible cause of severe illness in children and adults.
News from the FDA/CDC
Alzheimer’s Association to CMS: Ditch restraints on amyloid drugs
The CMS coverage restrictions for anti-amyloid drugs were finalized in April on the...
News from the FDA/CDC
FDA approves Idacio as eighth adalimumab biosimilar in U.S.
Data for Idacio (adalimumab-aacf) showed safety, efficacy, and immunogenicity similar to Humira.
News
FDA OKs first fecal transplant therapy for recurrent C. difficile
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
Feature
U.S. flu activity already at mid-season levels
Nationally, 6% of all outpatient visits were because of flu or flu-like illness for the week of Nov. 13-19.
News from the FDA/CDC
FDA alert: ‘Substantial’ hypocalcemia risk with denosumab use in dialysis patients
The Food and Drug Administration sent an alert that it’s investigating an apparent link between the use of denosumab (Prolia) by patients on...
News from the FDA/CDC
FDA approves first-ever agent to delay type 1 diabetes onset
Teplizumab delayed progression to clinical type 1 diabetes by about 2 years compared with placebo in individuals destined to develop the condition...
News from the FDA/CDC
FDA expands tenofovir alafenamide (Vemlidy) use to adolescents with chronic HBV
The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy.