Search results for Fda Cleared

<![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 ]]>

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[Pharmaceutical Executive Daily: FDA Approves Hepcludex]]>

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 Hepcludex as First and Only Approved Treatment for Chronic Hepatitis Delta Virus]]>

<![CDATA[FDA Clears Investigational New Drug Application for Phase Ib/IIa Trial of CK0802 in Steroid-Refractory Graft...

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[Travere Therapeutics’ Filspari Receives Full FDA Approval ]]>

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

FDA grants breakthrough designation for efimosfermin for MASH

The FDA granted breakthrough therapy designation to efimosfermin — an investigational, once-monthly fibroblast growth factor 21 analogue — for treatment of patients with metabolic...

Lilly’s new obesity pill passes heart safety test in diabetes

The findings, which come amid FDA scrutiny of Foundayo’s safety, will enable Lilly to seek a new clearance in diabetes.

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

FDA Green Lights Expanded Access to Pancreatic Cancer Drug, Daraxonrasib

MONDAY, May 4, 2026 — The U.S. Food and Drug Administration (FDA) granted expanded access for the use of an experimental pancreatic cancer drug, daraxonrasib. This means the drug w...

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

<![CDATA[Pharmaceutical Executive Daily: FDA Approves AstraZeneca's Fasenra]]>

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...

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

Zeto’s latest EEG device garners FDA 510(k) clearance for outpatient use

Zeto, which makes brainwave monitors for emergency rooms, received a third FDA clearance for an EEG device. The latest is intended for use in outpatient clinics or at home.

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

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...