Clinical Trials Arena on MSN

FDA unveils new pathway to usher bespoke therapies to market

The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...
BioPharma Dive

FDA unveils new regulatory roadmap for bespoke drug therapies

The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments ...
JD Supra

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...
Opinion
Yakima HeraldOpinion

Column: The FDA’s mifepristone decision has baffled both sides

The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to ...
Managed Healthcare Executive

FDA approves Poherdy, first biosimilar of Perjeta, to treat HER-positive breast cancer

Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...
Nasdaq

Larimar Therapeutics Announces FDA Recommendations on Safety Database, and Other Details of Nomlabofusp BLA Submission for Friedreich’s Ataxia Program

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 ...