Search results for Fda Drug Approvals

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

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

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

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[Pharmaceutical Executive Daily: FDA Approves Hepcludex]]>

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 Beqalzi and Inqovi]]>

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

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

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...

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...

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

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

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 Approves First Generic Farxiga (dapagliflozin) Tablets

April 7, 2026 -- The U.S. Food and Drug Administration approved the first generics of Farxiga (dapagliflozin) tablets to reduce the risk of hospitalization for heart failure in adu...

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

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

May 28 2026 - AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer

May 28 2026 - AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer admin Thu, 05/28/2026 - 11:51 Steady progress across the board today, with new appro...

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

FDA Makes Moves to Modernize Drug Development, Clinical Trial Paradigm

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” I...

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

<![CDATA[FDA Approves Bizengri for Adults with NRG1 Fusion-Positive Cholangiocarcinoma]]>

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