February 21, 2025

T-DXd Approved by the FDA for Pretreated Patients With HER2-Low or -Ultralow Metastatic Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has been approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HE...

The ASCO Post

February 21, 2025

FDA Approves First Cerebrotendinous Xanthomatosis Treatment

The FDA has approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disorder.

Conexiant

February 21, 2025

FDA Ends Semaglutide Shortage, Updates Policy

FDA declares resolution of nationwide semaglutide injection shortage and outlines 60 to 90 day transition periods for compounding facilities while other GLP-1 medications remain in limited supply.

Conexiant

February 21, 2025

FDA Approves Preparative Regimen for Allogeneic HSCT in Patients With AML or MDS

The FDA recently approved treosulfan (Grafapex), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric pat...

The ASCO Post

February 21, 2025

FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma

On January 16, the U.S. Food and Drug Administration (FDA) granted traditional approval to acalabrutinib (Calquence) with bendamustine and rituximab for adults with previously untreated mantle cell ly...

The ASCO Post

February 20, 2025

NY Sues Major Vape Distributors Over Youth Marketing

Attorney General Letitia James files lawsuit against 13 e-cigarette companies for allegedly targeting minors with flavored nicotine products, seeking hundreds of millions in damages and penalties.

Conexiant

February 19, 2025

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.

Conexiant

February 19, 2025

FDA Clears Novel Atopic Dermatitis Drug

FDA grants IND clearance to Zabalafin Hydrogel, a botanical drug targeting bacterial, inflammatory, and pruritic components of atopic dermatitis, following successful Phase 2a trials.

Conexiant

February 18, 2025

FDA Clears Aptima SARS-CoV-2 Assay for High-Throughput Testing

FDA grants 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, which uses the Panther system for high-throughput RNA detection.

Conexiant