The FDA is expected to decide on treatments for Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity.

Imlifidase is a Streptococcus pyogenes-derived cysteine protease that rapidly degrades immunoglobulin G antibodies within 2 to 6 hours of administration.

FDA reinspection, apitegromab BLA resubmission and 2026 launch outlook, plus cash and new debt facility—read now.

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

PDUFA action date set for August 23, 2026 If approved, DTX401 will be the first treatment to address the underlying cause of ...

Spruce Biosciences Inc has announced a revised schedule for its regulatory submission of TA-ERT, a potential treatment for Sanfilippo syndrome type B. While the ...

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available ...

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...