The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic ...

TRITON3 trial data support FDA traditional approval of rucaparib for treating adults with BRCA-mutated metastatic castration-resistant prostate cancer.

Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

An overview of the top 10 stories from Optometry Times in 2025.

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA Written FDA recommendations for safety database include a total of at least ...