FDA News

FDA Approves Label Update for Semaglutide as a First-line Type 2 Diabetes Medication
January 16, 2023

The update removes a previous limitation that stated semaglutide should not be used as an initial therapy for treating patients with T2D.

15 Drugs Approved for Primary Care in 2022
January 12, 2023

Get a quick look at 15 of the many FDA-approved drugs in 2022 for conditions commonly seen in primary care.

FDA Approves Novel Capsid Inhibitor for Super-Refractory HIV-1 Infection
December 23, 2022

Lenacapavir is the first of a new class of antiretrovirals, and it is indicated for persons with multidrug resistance, intolerance, or safety considerations.

5 New Drugs Approved for Primary Care: Q4 2022
December 15, 2022

The end of another quarter means a new list of FDA-approved drugs for conditions treated in primary care. Are you up-to-date? Click through to find out.

FDA Clears Dexcom G7 CGM System for Persons with T1D and T2D
December 14, 2022

The Dexcom G7 continuous glucose monitoring system provides an overall MARD of 8.2%, the highest of any FDA-cleared CGM, the company says.

FDA Grants Priority Review to Pfizer’s RSV Vaccine Candidate for Older Americans
December 08, 2022

The FDA has granted priority review to a biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate, RSVpreF, for adults aged ≥60 years.

FDA Authorizes Bivalent COVID-19 Vaccines as Booster Dose in Children Aged 6 Months to 5 Years
December 08, 2022

The FDA amended Pfizer and Moderna EUAs for updated COVID-19 vaccines to include children as young as age 6 months as holidays and winter weather approach.

FDA Grants Priority Review to sNDA for OTC Intranasal Naloxone HCl
December 07, 2022

The Agency's priority review of the prescription-OTC switch underscores the urgent need for broader access to the opioid overdose reversal agent.

First Live Microbiota Treatment for Recurrent CDI Wins FDA Approval
December 01, 2022

The single-dose biotherapeutic remained effective through 6 months for more than 90% of phased 3 clinical trial participants, according to Ferring Pharmaceuticals.

Daily Dose: High-risk Patients with Atrial Fibrillation Not Prescribed Anticoagulation
November 21, 2022

Your daily dose of clinical news you may have missed.