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Prescription & Medication Blog - FDA

Overview

Before any medication appears in U.S. pharmacies, it must first gain approval from the U.S. Food and Drug Administration (FDA). The FDA regulates all drugs and medical devices to ensure their safety and efficacy - this includes all over-the-counter medicine and prescription drugs, which have to pass through a rigorous approval process before being used in the the U.S..

These articles and resources include information on some of the latest and most notable new approvals by the FDA. New approvals sometimes mean exciting new treatments become available to help manage, treat or cure health conditions, or new options appearing for those already undergoing treatment.

As well as regulating the approval of new branded medicines, the FDA is also responsible for the approval process for new generic medications. Around 9 out of 10 prescriptions filled in the U.S. are generic medications, yet they only account for around 25% of the drug spend! Greater availability of generic drugs means more competitive prices at the pharmacy, cheaper prescriptions for patients and more affordable medication.

Find out more about:

  • New treatments and approvals
  • New generic alternative to expensive branded drugs
  • New medical device approvals, such as blood glucose monitors
  • Other FDA news and developments



Arriving home with a new baby is one of those special life events that new moms will always remember but it can also be an overwhelming and turbulent time. Consequently, it may be unsurprising that up to eight out of ten new mothers experience the “baby blues," a common phenomenon...

Read More... Apr 15, 2019

Patients with neutropenia may have improved access to treatment following the US Food and Drug Administration’s (FDA’s) approval of Nivestym (filgrastim-aafi), a biosimilar for Amgen biologic Neupogen (filgrastim).  The FDA’s approval of the biosimilar was based on a review...

Read More... Jul 31, 2018

Epidiolex (cannabidiol) is the first medication based on a purified drug substance, cannabidiol (CBD), derived from marijuana to gain approval from the US Food and Drug Administration (FDA). The drug is indicated for patients aged two years and older with Lennox-Gastaut syndrome or Dravet...

Read More... Jul 11, 2018

The US Food and Drug Administration (FDA) has approved the protein kinase inhibitor Tagrisso (osimertinib) as a first-line treatment option for certain patients with metastatic non-small cell lung carcinoma (NSCLC). Earlier this month, AstraZeneca presented new data from a Phase III FLAURA trial...

Read More... Apr 24, 2018

The US Food and Drug Administration (FDA) has approved Crysvita (burosumab) as a treatment for a rare form of inherited rickets. It is the first drug therapy approved as a treatment for x-linked hypophosphatemia (XLH) with evidence of bone disease in children over one year of age and adolescents...

Read More... Apr 18, 2018