Search results for Drug Approval

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

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

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

Regulatory Overview: Post-Approval Changes to Marketed Drugs

The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternativ...

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

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Beqalzi and Inqovi]]>

Biotech Insights - Spring 2026

Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...

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

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

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

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

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

Travere wins long-awaited approval for kidney disease drug

The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually. 

When the FDA Says “No” After Saying “Yes”: What the RP1 Decision Gets Wrong

When the FDA Says “No” After Saying “Yes”: What the RP1 Decision Gets Wrong Anonymous (not verified) Wed, 04/22/2026 - 11:12 pharmagather item url When the...

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

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...

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[ICER and Verdant Research Publish White Paper Examining FDA’s Accelerated Approval Pathway]]>

FDA Signals it Has No Appetite to Add Popular GLP-1 Drug Substances to the 503B Bulks List

Key Takeaways FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. The proposal would materially limit 503B bulk compounding of these GLP-...

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 Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List

On April 30, 2026, the U.S. Food and Drug Administration (FDA) announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List (“5...

<![CDATA[Pharmaceutical Executive Daily: FDA Extends Review of Leqembi's sBLA]]>

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

<![CDATA[FDA Approves Hepcludex as First and Only Approved Treatment for Chronic Hepatitis Delta Virus]]>