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 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).

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 ...

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 ...

Artificial intelligence isn't performing surgery yet, but if (when?) it does, these two companies are likely to be at the ...

A free training program aimed at preparing people for union apprenticeship is expanding into Kane County with a location in Aurora.

Intuitive Surgical ISRG recently announced that the FDA has granted 510(k) clearance for the da Vinci 5 system to be used in ...