Search results for Fda Breakthr...

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

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...

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

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

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

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 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...

<![CDATA[Travere Therapeutics’ Filspari Receives Full FDA Approval ]]>

FDA To Review Whether To Allow More Access To Certain Peptides

FRIDAY, April 17, 2026 — The U.S. Food and Drug Administration (FDA) will soon review whether certain peptides should be allowed in customized medications made by compounding phar...

May 11 2026 - FDA mulls repurposing approved drugs to expand access

May 11 2026 - FDA mulls repurposing approved drugs to expand access admin Mon, 05/11/2026 - 11:47 From FDA policy signals to big strategic goals, today’s headlines...

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

<![CDATA[FDA Places Full Clinical Hold on Aardvark Therapeutics’ ARD-101]]>

<![CDATA[Pharmaceutical Executive Daily: Idvynso Receives FDA Approval]]>

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

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...

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

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

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

<![CDATA[Pharmaceutical Executive Daily: FDA Issues CRL to AbbVie]]>

<![CDATA[FDA’s Oncologic Drugs Advisory Committee Recognizes Favorable Risk Benefit for Truqap ]]>

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

<![CDATA[FDA Issues CRL to Replimune for RP1 Biologics License Application for Advanced Melanoma Treatment ]]>

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

<![CDATA[FDA Issues CRL to AbbVie for TrenibotulinumtoxinE’s Biologics License Application ]]>

FDA Approves New Weight Loss Pill, Foundayo, in Record Time

THURSDAY, April 2, 2026 — A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved through review faster than most d...