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<![CDATA[FDA Pannel Votes to Loosen Restrictions for Four Peptides ]]>

<![CDATA[FDA Approves Pasatru For Adults With Fibrodysplasia Ossificans Progressiva ]]>

FDA steps up import enforcement on infant formula, seafood, dried peppers

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

<![CDATA[FDA Clears Consano’s IND for C-1101 ]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]>

FDA Wants More Information From Food Makers On New Food Chemicals

WEDNESDAY, Aug. 12, 2026 — For decades, food manufacturers have been able to decide what food chemicals were safe enough to add to their products based on general government guidel...

<![CDATA[FDA Approves Lipfendra to reduce LDL-C in Adults with Hypercholesterolemia ]]>

FDA seeks greater oversight of food ingredients through proposed GRAS rule changes

The Food and Drug Administration says it is taking steps to increase transparency in the food safety system.  Acting commissioner Kyle Diamantas says the FDA has proposed changes t...

FDA Panel Backs Two Peptides For Compounding, Rejects One

MONDAY, July 27, 2026 — A federal advisory panel has recommended allowing compounding pharmacies to make two more unproven peptides while voting to reject a third.The U.S. Food an...

FDA panel to consider loosening regulations for some peptides

The FDA panel will review seven peptides and decide if they should be added to a list of substances that can be safely produced by compounding pharmacies.

FDA DG inspects One Window Counter

HHS Proposes Reforms to the “Generally Recognized As Safe” Pathway

On August 10, 2026, Department of Health and Human Services (HHS) Secretary Robert Kennedy made two major announcements related to the...

U.S. FDA Leadership from Three Centers and OII Headline the Center Office Updates Session of the 2026 PDA/FDA Joint Regu...

PDA announced today that senior leaders from the FDA's centers for drugs, biologics and veterinary medicine as well as the Office of Inspections and Investigations will participate...

FDA warns Florida supplement maker about sanitation and allergen risks

As part of its enforcement activities, the U.S. Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view u...

<![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>

When the Label Lags the Science: Using 505(o)(4) to Compel Labeling Changes

By Sara W. Koblitz —

<![CDATA[FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults ]]>

<![CDATA[FDA Grants Accelerated Approval to Tudriqev in Combination with Nivoumab for Advanced Melanoma]]>

FDA warns three California importers about Foreign Supplier Verification Program failures

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

<![CDATA[What FDA's Peptide Decision Means for the Industry]]>

FDA panel narrowly backs unapproved peptide drugs favored by RFK Jr.

A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from gover...

FRIDAY HEALTH REPORT: Peptides sold online without FDA approval may soon be available by prescription

WASHINGTON — An FDA advisory panel is reviewing whether compounding pharmacies should be allowed to manufacture seven specific peptides, which could make them easier to a...

FDA letter reinforces responsibilities of infant formula supply chain

The FDA has put the entire infant formula supply chain on notice to improve monitoring and production practices.The decree comes amid a second outbreak since November 2025 of infan...

<![CDATA[FDA Approves Otsuka’s First-In-Class Simtriyo for Adults & Pediatric Patients ]]>