Search results for Fda

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

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

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...

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

FDA Releases Final Documents for Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT and A...

The U.S. Food and Drug Administration announced on May 12, 2026, “two decisive actions focused on food chemical safety.” First, FDA released two final documents for its new proacti...

<![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 —

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[Pharmaceutical Executive Daily: FDA Approves Datroway]]>

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...

Dietary Supplement Companies, Natural Medicine Group Sue FDA Over Health Claims

A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercia...

FDA Finalizes Post-Market Assessment Program

On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytolu...

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...

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...

FDA Authorizes Glas Flavored ENDS Products, Opening an Age-Gating Pathway for Flavors

On May 5, 2026, the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for four Glas closed-pod electronic nicotine delivery system (ENDS) products: Cla...

Bipartisan Push for FDA “Pre-Review” of DTC Drug Ads

By Charles D. Snow & Dara Katcher Levy —

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

FDA Infant Formula Testing Confirms Safety of U.S. Supply

On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in...

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...

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Imme...

FDA Finalizes Systematic Post-Market Food Chemical Review Process

The agency also announced the launch of reassessments for butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).

FDA to weigh easing limits on unproven peptides promoted by RFK Jr.

The Food and Drug Administration will hold a meeting this summer to consider easing restrictions on more than a half dozen peptide injections, a group of unapproved therapies that...

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

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...