FDA Issues Warning About Probiotics Sold for Preterm Infants
On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to...Pfizer, BioNTech Reveals Data on Combined COVID and Flu Vaccine
Pfizer and its partner, BioNTech, announced positive clinical trial data for an mRNA-based combined vaccine for influenza and COVID-19. The announcement highlights data from a phase 1/2 clinical study...CDC Urges Rationing of New Antibody Shot for Infant RSV Protection
In response to the overwhelming demand for the newly approved antibody shot, Beyfortus, designed to safeguard newborns from respiratory syncytial virus (RSV), the Centers for Disease Control and...FDA Reviews AstraZeneca’s Self-Administered Flu Vaccine, FluMist
In a landmark development in the world of healthcare, AstraZeneca's FluMist Quadrivalent is set to revolutionize flu vaccination by potentially becoming the first and only self-administered flu...NIH Alters Grant Review Process, Focusing on Scientific Merit
On October 19, 2023, the National Institutes of Health (NIH) announced plans to alter and simplify its grant review process, attempting to eliminate reputational bias in grant allocation. The updated...FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain
Earlier this week, Hyloris Pharmaceuticals, a pharmaceutical company headquartered in Belgium, announced the approval of a potent non-opioid painkiller in the United States. The US Food and Drug...FDA Proposes Ban on Formaldehyde Hair Smoothing, Straightening Products
A proposed rule by the United States Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) has proposed banning hair products that contain formaldehyde or...HHS and Pfizer Reach Paxlovid Agreement to Improve Access
Last week, the United States Department of Health and Human Services (HHS) announced that it had negotiated an agreement with Pfizer Inc. to bolster access to Paxlovid as it enters the commercial...Antifungal Therapeutic Drug Monitoring Are Rates Lower Than Use Rates
According to the results of an article published in Open Forum Infectious Diseases, infectious disease specialists are not monitoring antifungal prescriptions at the same rates they are prescribing...Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings
Last week, the United States Food and Drug Administration (FDA) issued two warning letters to online vendors selling unauthorized versions of semaglutide and tirzepatide, active ingredients in...DEA Extends Telemedicine Prescription of Controlled Medicines
In an announcement on October 6, 2023, the United States Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) announced that they would extend the COVID-19...FDA Updates Infant Formula Compliance Program
To minimize the risk of contaminated infant formula, the United States Food and Drug Administration (FDA) updated its infant formula compliance program, announcing the changes on October 6, 2023. Last...Sponsored by Optum
Controlling Oncology Costs with Cross-Benefit Drug Management
The oncology care landscape is dynamic, shaped by rising cancer medication expenses, medical advancements, and the persistent influence of outside challenges like COVID-19. To navigate this complexity...FDA Issues Guidance on Drug Development for Stimulant Use Disorders
On October 4, 2023, the United States Food and Drug Administration (FDA) released a draft guidance titled Stimulant Use Disorders: Developing Drugs for Treatment. The recommendations suggest protocols...CDC Recommends Doxycycline PEP to Prevent STIs
Earlier this week, the Centers for Disease Control and Prevention (CDC) published a draft guidance for the use of doxycycline, a common antibiotic, as a post-exposure prophylaxis (PEP) treatment to...FDA Authorizes Novavax COVID-19 Vaccines for Circulating Variants
Yesterday, on October 3, 2023, the United States Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against the...Sponsored by Optum