Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs ...

Tenpoint Therapeutics announced FDA’s approval of Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% ...

In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

Wide-ranging shifts at the FDA have set the stage for decisions that drag the agency through the political mud, according to ...

The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.

Hunter syndrome (MPS II) presentations will include analysis from continued follow-up of Phase 1/2 data for tividenofusp alfa (DNL310), currently under FDA Priority ReviewPreliminary data from Phase 1 ...

Executive Vice President of Commercial Marion McCourt highlighted "EYLEA HD net sales reached $506 million, representing 18% sequential growth" and noted "new real-world market data shows that on ...

The U.S. Food and Drug Administration (FDA) has granted Biogen’s investigational drug, litifilimab, Breakthrough Therapy Designation for the treatment of cutaneous lupus erythematosus (CLE).