article thumbnail

Tarpeyo (Budesonide) Is Transforming IgA Nephropathy Care with FDA’s Full Approval

XTalks

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

article thumbnail

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. pharmacies. and arguably just as safe. Let’s call him John. Is the drug safe? Is it counterfeit?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

How the US’s pending PIE Act will improve patient access to medication

pharmaphorum

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

article thumbnail

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

article thumbnail

Phase two CD19-antibody-drug conjugate trial demonstrates promise for aggressive lymphoma

Bioengineer

The phase 2 trial result led to Food and Drug Administration (FDA) approval of Loncastuximab tesirine as a single agent. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy.

Trials 52
article thumbnail

Trans Healthcare: How Pharma Marketers Can Positively Impact This Underserved Community

Intouch Solutions

It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it. “I The reasons vary, but one of the most recent shortages of synthetic estrogen has largely been chalked up to a delay in FDA approval.

article thumbnail

CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care

FDA Law Blog

In addition, the guideline has been misapplied to cancer and palliative care patients, and there have been rapid opioid tapers without patient collaboration, rigid application of opioid dosage thresholds, application of opioid use for pain to opioid use disorder treatment, insurer and pharmacy duration limits, patient dismissals and abandonment.