Search results for Fda Approval

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

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

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

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

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

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

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[Pharmaceutical Executive Daily: Idvynso Receives FDA Approval]]>

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...

<![CDATA[FDA Approves Caplyta for Prevention of Schizophrenia in Adults ]]>

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

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

<![CDATA[FDA Approves Idvynso for Treatment of HIV-1 Infection in Adults]]>

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

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 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 Approves Fasenra for Hypereosinophilic Syndrome]]>

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

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

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

FDA approves Bizengri as first treatment for adults with rare bile duct cancer

The FDA has approved zenocutuzumab-zbco as the first drug for certain patients with a rare and aggressive bile duct cancer.Zenocutuzumab-zbco (Bizengri, Partner Therapeutics) recei...

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

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