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

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 ...

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

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 ...

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 ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

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 ...

The FDA has approved Jascayd (nerandomilast) as a treatment for a second lung disease, progressive pulmonary fibrosis, following the drug’s initial approval in October 2025 as a treatment for ...

Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with ...

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 ...