FDA News

FDA Approves New Antibiotic for Uncomplicated UTI: Daily Dose
May 03, 2024

Your daily dose of the clinical news you may have missed.

The Pipeline for New MASLD & MASH Treatments is Promising, says Naim Alkhouri, MD
April 30, 2024

Following the landmark FDA approval of resmetirom for MASH with fibrosis, hepatologist and researcher Alkhouri describes more mid- and late-stage candidates.

The FDA Approval of Resmetirom for MASH Changes Everything—for Patients and their Physicians
April 26, 2024

Naim Alkhouri, MD, a transplant hepatologist and a resmetirom investigator, talks here about the life-changing impact the drug will have for all touched by MASH.

FDA Approves First New Antibiotic in Decades for Uncomplicated UTI
April 25, 2024

Pivmecillinam is an aminopenicillin, a class of beta-lactam antibiotics with a mechanism of action that may help reduce rising levels of antibiotic resistance.

Vedolizumab (Entyvio) SC Approved for Maintenance Therapy in Adults with Moderately to Severely Active Crohn Disease
April 22, 2024

Vedolizumab for subcutaneous injection in now indicated for maintenance therapy following IV induction in both Crohn disease and ulcerative colitis.

FDA Approves Benralizumab as Add-On Maintenance Therapy for Children with Severe Asthma: Daily Dose
April 19, 2024

Your daily dose of the clinical news you may have missed.

How the CLEAR Outcomes Trial Made CV Risk Reduction History, with Lead Investigator Steven Nissen, MD
April 18, 2024

Bempedoic acid became the first nonstatin LDL-C lowering medication indicated to reduce CV risk in both primary and secondary prevention. Nissen explains how.

FDA Approves Benralizumab as Add-On Maintenance Therapy for Children Aged 6-11 Years with Severe Asthma
April 11, 2024

The additional indication for benralizumab was supported by data from the phase 3 TATE trial.

FDA Clears First AI-Based Algorithm to Detect Heart Failure during Routine Exams
April 03, 2024

The Low EF AI is designed to detect low ejection fraction in 15 seconds during a primary care exam.

FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets for PAH: Daily Dose
April 03, 2024

Your daily dose of the clinical news you may have missed.