The FDA is expected to decide on treatments for breast cancer, EBV+ post-transplant lymphoproliferative disease, focal segmental glomerulosclerosis, presbyopia, and severe allergic reactions.

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 ...

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 ...

The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs. The new app, called Drugs@FDA Express, is free and currently ...

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 ...

One of the more competitive targets in lung cancer is a certain mutation that has eluded many available targeted therapies. A drug developed by Dizal Pharmaceutical has received FDA approval for ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The US FDA has approved two companies’ COVID vaccines that target the latest variant of the virus for adults aged at least 65 years and individuals at high risk for severe outcomes, according to ...

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 ...