Search results for Fda

<![CDATA[FDA Approves Foundayo Under National Priority Voucher Program]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Datroway]]>

The FDA Cracks Down on Tavneos

The FDA Cracks Down on Tavneos Anonymous (not verified) Thu, 04/30/2026 - 14:18 pharmagather item url The FDA Cracks Down on Tavneos pha...

New Weight Loss Pill, Foundayo, Gets Approval But FDA Seeks More Safety Data

WEDNESDAY, April 15, 2026 — The U.S. Food and Drug Administration (FDA) has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo, acc...

FDA warns three importers for failing to verify safety of imported foods

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...

FDA Announces FSMA 204 Compliance Training Through FSPCA

The Food Traceability Rule training, offered through the Food Safety Preventive Controls Alliance (FSPCA), provides industry participants with foundational knowledge needed to unde...

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...

FDA warns New York firm for failing to verify safety of imported foods

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...

FDA steps up enforcement actions on imported cheese, seafood, dried peppers and more

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...

Seafood, papayas among imports under greater scrutiny by FDA

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...

FDA proposes rule to fast-track oral fluid and hair drug testing

The FDA moves to eliminate the 510(k) hurdle for oral fluid drug testing, a major win for the ATA and safety-sensitive industries...

<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>

<![CDATA[FDA Approves Fasenra for Hypereosinophilic Syndrome]]>

<![CDATA[FDA's Timeline for DTC Prescription Drug Ad Oversight]]>

<![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>

FDA asks Lilly to evaluate obesity pill’s liver risk

The request, which is part of a just-released approval letter for Foundayo, comes amid an intensifying marketing battle between Lilly and Novo.

<![CDATA[FDA’s Shift Signals a New Era for Data-Driven Drug Development]]>

FDA steps up enforcement on imported cheese, canned food, seafood and more

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...

FDA increases import enforcement on certain cheese, seafood, cilantro

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...

FDA Supports Grouping Several Phthalates for Cumulative Risk Assessment

FDA published a literature review on the eight phthalates currently approved for food contact uses to determine whether they should be considered chemically and/or pharmacologicall...

<![CDATA[FDA Approves Datroway for Patients with Metastatic Triple-Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhi...

New Weight Loss Pill Gets Approval But FDA Seeks More Safety Data

WEDNESDAY, April 15, 2026 — The U.S. Food and Drug Administration (FDA) has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo, ac...

Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies

By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —

FDA warns three firms after finding rodents, bird droppings and allergen risks in food facilities

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...