Diana Ernst, RPh

Positive results were announced from a phase 3 trial evaluating a next-generation, low-dose copper IUD for the prevention of pregnancy.

The FDA has granted Fast Track designation to LMN-201 for the treatment and prevention of C. difficile infection.

The FDA has finalized individual risk-based questions to assess blood donor eligibility and reduce the risk of transfusion-transmitted HIV.

The FDA has approved Elfabrio® (pegunigalsidase alfa-iwxj) for the treatment of adults with confirmed Fabry disease.

FDA joint panel vote unanimously to allow for Rx to OTC switch of progestin-only contraceptive pill Opill.

The FDA has approved the Medtronic MiniMed 780G system with the Guardian 4 sensor for patients 7 years of age and older with type 1 diabetes.

A generic version of Uceris has been made available by Padagis, who was granted 180 days of Competitive Generic Therapy exclusivity.

The FDA has rejected the application for mirikizumab for treating ulcerative colitis due to issues related to its proposed manufacturing.

Merck and Eisai announced disappointing results from 2 clinical trials evaluating pembrolizumab (Keytruda) with lenvatinib (Lenvima).

The FDA has granted Fast Track designation to PBP1510 (ulenistamab) for the treatment of unresectable or metastatic pancreatic cancer.

Previously, the treatment had been approved for patients 1 year of age and older.

To better understand the new phenomenon of “patient influencers”, the authors conducted interviews with individuals who routinely offer advice on health topics on social media.

The FDA had required manufacturers of prescription acetaminophen combination products to limit the amount of acetaminophen to 325mg per tablet or capsule.

Several changes have been made to the adult immunization schedule 2023.

Results showed vaccine efficacy of 83.7% against RSV-LRTD, defined by 2 or more symptoms.

Based on the information presented at the meeting, the FDA will make a decision on the best course of action regarding adjustments to current authorizations and approvals.

As part of the Choosing Wisely campaign, the American Academy of Pediatrics (AAP) has released a new list of 5 tests and procedures commonly ordered in pediatric emergency medicine that physicians and patients should question. Choosing Wisely is an American Board of Internal Medicine (ABIM) Foundation initiative that aims to promote discussions between clinicians and…

Immune responses after Priorix administration were noninferior to those observed with M-M-R II.

Semaglutide is a glucagon-like peptide-1 receptor agonist.

Researchers used data from the State Unintentional Drug Overdose Reporting System in order to assess trends in gabapentin-involved overdose deaths.

The submission includes data from a phase 2/3 clinical trial that assessed the safety, tolerability and immunogenicity of a third dose (10µg booster) in 140 children 5 to 11 years of age.

The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.

A list of FDA authorized COVID-19 home tests.

The randomized, double-blind, placebo controlled, fully remote study was led by The Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory.

Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2.

Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis.

An expert panel assessed 40 diets to come up with the final results, examining the evidence behind each diet’s claims.

The independent study conducted by Dan Barouch, MD, PhD, et al of Beth Israel Deaconess Medical Center included a subset of participants from the COV2008 study.

A new booster candidate specific for Omicron is also being planned.

Both Companies provided data demonstrating waning neutralizing antibody titers approximately 6 months after completion of the primary series.